{"id":"bacteriostatic-water-for-injection-in-plastic-container","_fda":{"id":"2b39b41d-419a-dab8-e063-6394a90a319a","set_id":"99e99a50-82d5-aff6-e053-2a95a90a8c56","openfda":{"unii":["059QF0KO0R"],"route":["INTRAMUSCULAR","INTRAVENOUS","SUBCUTANEOUS"],"spl_id":["2b39b41d-419a-dab8-e063-6394a90a319a"],"brand_name":["Sterile Water"],"spl_set_id":["99e99a50-82d5-aff6-e053-2a95a90a8c56"],"package_ndc":["64253-020-21","64253-020-23","64253-020-30","64253-020-35","64253-020-52","64253-020-25","64253-020-91"],"product_ndc":["64253-020"],"generic_name":["STERILE WATER FOR INJECTION"],"product_type":["HUMAN PRESCRIPTION DRUG"],"substance_name":["WATER"],"manufacturer_name":["Medefil, Inc."],"application_number":["ANDA211188"],"is_original_packager":[true]},"version":"5","warnings":["Intravenous administration of Sterile Water for Injection without a solute may result in hemolysis"],"pregnancy":["Pregnancy Category C. Animal reproduction studies have not been conducted with Sterile Water for Injection. It is also not known whether sterile water containing additives can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Sterile Water for Injection with additives should be given to a pregnant woman only if clearly needed."],"overdosage":["Use only as a diluent or solvent. This parenteral preparation is unlikely to pose a threat of fluid overload except possibly in neonates or very small infants. In the event these should occur, re-evaluate the patient and institute appropriate corrective measures. See WARNINGS , PRECAUTIONS and ADVERSE REACTIONS ."],"description":["This preparation is designed solely for parenteral use only after addition of drugs that require dilution or must be dissolved in an aqueous vehicle prior to injection. Sterile Water for Injection, USP is a sterile, nonpyrogenic preparation of water for injection which contains no bacteriostat, antimicrobial agent or added buffer and is supplied only in single-dose containers to dilute or dissolve drugs for injection. For intravenous injection, add sufficient solute to make an approximately isotonic solution. pH 5.0 to 7.0. Water for Injection, USP is chemically designated H2O. The plastic syringe is molded from a specially formulated polypropylene. Water permeates from inside the container at an extremely slow rate which will have an insignificant effect on solution concentration over the expected shelf life. Solutions in contact with the plastic container may leach our certain chemical components from the plastic in very small amounts; however, biological testing was supportive of the safety of the syringe material."],"precautions":["Do not use for intravenous injection unless the osmolar concentration of additives results in an approximate isotonic admixture. Consult the manufacturer's instructions for choice of vehicle, appropriate dilution or volume for dissolving the drugs to be injected, including the route and rate of injection. Inspect reconstituted (diluted or dissolved) drugs for clarity (if soluble) and freedom from unexpected precipitation or discoloration prior to administration. Pregnancy Category C. Animal reproduction studies have not been conducted with Sterile Water for Injection. It is also not known whether sterile water containing additives can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Sterile Water for Injection with additives should be given to a pregnant woman only if clearly needed. Safety and effectiveness have been established in pediatric patients. However, in neonates or very small infants the volume of fluid may affect fluid and electrolyte balance. Some drugs for injection may be incompatible in a given vehicle, or when combined in the same vehicle or in a vehicle containing benzyl alcohol. Consult with pharmacist, if available. When diluting or dissolving drugs, mix thoroughly and use promptly. Do not store reconstituted solutions of drugs for injection unless otherwise directed by the manufacturer of the solute. Do not use unless the solution is clear and seal intact. Do not reuse single-dose containers. Discard unused portion. Some drugs for injection may be incompatible in a given vehicle, or when combined in the same vehicle or in a vehicle containing benzyl alcohol. Consult with pharmacist, if available. When diluting or dissolving drugs, mix thoroughly and use promptly. Do not store reconstituted solutions of drugs for injection unless otherwise directed by the manufacturer of the solute. Do not use unless the solution is clear and seal intact. Do not reuse single-dose containers. Discard unused portion."],"how_supplied":["Sterile Water for Injection, USP is supplied in the following: Product NDC Number Sterile Water for Injection, USP 1 mL, Single-dose pre-filled syriinge, carton of 10s 64523-020-41 Sterile Water for Injection, USP 2.5 mL, Single-dose pre-filled syringe, carton of 10s 64253-020-51 Sterile Water for Injection, USP 3 mL, Single-dose pre-filled syringe, carton of 10s 64253-020-61 Sterile Water for Injection, USP* 5 mL, Single-dose pre-filled syringe, carton of 10s 64253-020-71 Sterile Water for Injection, USP** 5 mL, Single-dose pre-filled syringe, carton of 10s 64253-020-81 Sterile Water for Injection, USP 10 mL, Single-dose pre-filled syringe, carton of 10s 64253-020-91 Sterile Water for Injection, USP 1 mL, Single-dose pre-filled syringe, carton of 60s 64253-020-21 Sterile Water for Injection, USP 2.5 mL, Single-dose pre-filled syringe, carton of 60s 64253-020-52 Sterile Water for Injection, USP 3 mL, Single-dose pre-filled syringe, carton of 60s 64253-020-23 Sterile Water for Injection, USP* 5 mL, Single-dose pre-filled syringe, carton of 60s 64253-020-25 Sterile Water for Injection, USP** 5 mL, Single-dose pre-filled syringe, carton of 60s 64253-020-35 Sterile Water for Injection, USP 10 mL, Single-dose pre-filled syringe, carton of 60s 64253-020-30 *in 6 mL Syringe **in 12 mL Syringe Discard unused portion Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.]. Protect from freezing"],"pediatric_use":["Safety and effectiveness have been established in pediatric patients. However, in neonates or very small infants the volume of fluid may affect fluid and electrolyte balance."],"effective_time":"20250108","adverse_reactions":["Reactions which may occur because of this solution, added drugs or the technique of reconstitution or administration include febrile response, local tenderness, abscess, tissue necrosis or infection at the site of injection, venous thrombosis or phlebitis extending from the site of injection and extravasation. If an adverse reaction does occur, discontinue the infusion, evaluate the patient, institute appropriate countermeasures, and if possible, retrieve and save the remainder of the unused vehicle for examination. To report SUSPECTED ADVERSE REACTIONS, contact Medefil, Inc., at 1-630-682-4600 or www.medefilinc.com or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . Reactions which may occur because of this solution, added drugs or the technique of reconstitution or administration include febrile response, local tenderness, abscess, tissue necrosis or infection at the site of injection, venous thrombosis or phlebitis extending from the site of injection and extravasation. If an adverse reaction does occur, discontinue the infusion, evaluate the patient, institute appropriate countermeasures, and if possible, retrieve and save the remainder of the unused vehicle for examination. To report SUSPECTED ADVERSE REACTIONS, contact Medefil, Inc., at 1-630-682-4600 or www.medefilinc.com or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch ."],"contraindications":["Sterile Water for Injection, USP must be made approximately isotonic prior to use. Sterile Water for Injection, USP must be made approximately isotonic prior to use."],"drug_interactions":["Some drugs for injection may be incompatible in a given vehicle, or when combined in the same vehicle or in a vehicle containing benzyl alcohol. Consult with pharmacist, if available. When diluting or dissolving drugs, mix thoroughly and use promptly. Do not store reconstituted solutions of drugs for injection unless otherwise directed by the manufacturer of the solute. Do not use unless the solution is clear and seal intact. Do not reuse single-dose containers. Discard unused portion. Some drugs for injection may be incompatible in a given vehicle, or when combined in the same vehicle or in a vehicle containing benzyl alcohol. Consult with pharmacist, if available. When diluting or dissolving drugs, mix thoroughly and use promptly. Do not store reconstituted solutions of drugs for injection unless otherwise directed by the manufacturer of the solute. Do not use unless the solution is clear and seal intact. Do not reuse single-dose containers. Discard unused portion."],"how_supplied_table":["
ProductNDC Number
Sterile Water for Injection, USP1 mL, Single-dose pre-filled syriinge, carton of 10s64523-020-41
Sterile Water for Injection, USP2.5 mL, Single-dose pre-filled syringe, carton of 10s64253-020-51
Sterile Water for Injection, USP3 mL, Single-dose pre-filled syringe, carton of 10s64253-020-61
Sterile Water for Injection, USP*5 mL, Single-dose pre-filled syringe, carton of 10s64253-020-71
Sterile Water for Injection, USP**5 mL, Single-dose pre-filled syringe, carton of 10s64253-020-81
Sterile Water for Injection, USP10 mL, Single-dose pre-filled syringe, carton of 10s64253-020-91
Sterile Water for Injection, USP1 mL, Single-dose pre-filled syringe, carton of 60s64253-020-21
Sterile Water for Injection, USP2.5 mL, Single-dose pre-filled syringe, carton of 60s64253-020-52
Sterile Water for Injection, USP3 mL, Single-dose pre-filled syringe, carton of 60s64253-020-23
Sterile Water for Injection, USP*5 mL, Single-dose pre-filled syringe, carton of 60s64253-020-25
Sterile Water for Injection, USP**5 mL, Single-dose pre-filled syringe, carton of 60s64253-020-35
Sterile Water for Injection, USP10 mL, Single-dose pre-filled syringe, carton of 60s64253-020-30
"],"clinical_pharmacology":["Water is an essential constituent of all body tissues and accounts for approximately 70% of total body weight. Average normal adult daily requirement ranges from two to three liters (1.0 to 1.5 liters each for insensible water loss by perspiration and urine production). Water balance is maintained by various regulatory mechanisms. Water for distribution depends primarily on the concentration of electrolytes in the body compartments and sodium (Na+) plays a major role in maintaining physiologic equilibrium. The small volume of fluid provided by Sterile Water for Injection, USP when used only as a Pharmaceutic aid for diluting or dissolving drugs for parenteral injection, is unlikely to exert a significant effect on fluid balance except possibly in neonates or very small infants."],"indications_and_usage":["This parenteral preparation is indicated only for diluting or dissolving drugs for intravenous, intramuscular or subcutaneous injection, according to instructions of the manufacturer of the drug to be administered. This parenteral preparation is indicated only for diluting or dissolving drugs for intravenous, intramuscular or subcutaneous injection, according to instructions of the manufacturer of the drug to be administered."],"dosage_and_administration":["The volume of the preparation to be used for diluting or dissolving any drug for injection is dependent on the vehicle concentration, dose and route of administration as recommended by the manufacturer. This parenteral should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. The volume of the preparation to be used for diluting or dissolving any drug for injection is dependent on the vehicle concentration, dose and route of administration as recommended by the manufacturer. This parenteral should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit."],"spl_product_data_elements":["Sterile Water Sterile Water for Injection WATER WATER"],"package_label_principal_display_panel":["Syringe Label - 1 mL Box Label - 1 mL","Syringe Label - 2.5 mL Box Label - 2.5 mL","Syringe Label - 3 mL Box Label - 3 mL","Syringe Label - 5 mL Box Label - 5 mL","L4298 Rev. 002 - 10 mL L4303 Rev. 000 - 10 mL","Syringe Label - 5 mL Box Label - 5 mL","Dispenser Box 10 Count - 10 mL","Package Insert Rev 002 - Page 1 Package Insert Rev 002-Page 2","Pouch Label - 10 mL"]},"fdaNDC":[{"route":["INTRAMUSCULAR","INTRAVENOUS","SUBCUTANEOUS"],"labeler":"Medefil, Inc.","brandName":"Sterile Water","packaging":[{"ndc":"64253-020-21","description":"60 SYRINGE, PLASTIC in 1 BOX (64253-020-21) / 1 mL in 1 SYRINGE, PLASTIC","marketingStartDate":"20200127"},{"ndc":"64253-020-23","description":"60 SYRINGE, PLASTIC in 1 BOX (64253-020-23) / 3 mL in 1 SYRINGE, PLASTIC","marketingStartDate":"20200127"},{"ndc":"64253-020-25","description":"60 SYRINGE, PLASTIC in 1 BOX (64253-020-25) / 5 mL in 1 SYRINGE, PLASTIC","marketingStartDate":"20200921"},{"ndc":"64253-020-30","description":"60 SYRINGE, PLASTIC in 1 BOX (64253-020-30) / 10 mL in 1 SYRINGE, PLASTIC","marketingStartDate":"20200127"},{"ndc":"64253-020-35","description":"60 SYRINGE, PLASTIC in 1 BOX (64253-020-35) / 5 mL in 1 SYRINGE, PLASTIC","marketingStartDate":"20200127"},{"ndc":"64253-020-52","description":"60 SYRINGE, PLASTIC in 1 BOX (64253-020-52) / 2.5 mL in 1 SYRINGE, PLASTIC","marketingStartDate":"20200127"},{"ndc":"64253-020-91","description":"10 SYRINGE, PLASTIC in 1 BOX (64253-020-91) / 10 mL in 1 SYRINGE, PLASTIC","marketingStartDate":"20200921"}],"dosageForm":"INJECTION, SOLUTION","genericName":"Sterile Water for Injection","productType":"HUMAN PRESCRIPTION DRUG","activeIngredients":[{"name":"WATER","strength":"100 mL/100mL"}],"marketingCategory":"ANDA"},{"route":[],"labeler":"ROVI Pharma Industrial Services S.A.","brandName":"","packaging":[{"ndc":"50024-001-00","description":"1200 SYRINGE, GLASS in 1 BOX (50024-001-00) / .5 mL in 1 SYRINGE, GLASS","marketingStartDate":"01-SEP-14"}],"dosageForm":"INJECTION","genericName":"Sterile Water for Injection","productType":"BULK INGREDIENT","activeIngredients":[{"name":"WATER","strength":".5 mL/mL"}],"marketingCategory":"BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING"},{"route":[],"labeler":"ROVI Pharma Industrial Services S.A.","brandName":"","packaging":[{"ndc":"50024-002-00","description":"1500 SYRINGE, GLASS in 1 BOX (50024-002-00) / 1.05 mL in 1 SYRINGE, GLASS","marketingStartDate":"01-SEP-14"}],"dosageForm":"INJECTION","genericName":"Sterile Water for Injection","productType":"BULK INGREDIENT","activeIngredients":[{"name":"WATER","strength":"1.05 mL/1.05mL"}],"marketingCategory":"BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING"},{"route":[],"labeler":"ROVI Pharma Industrial Services S.A.","brandName":"","packaging":[{"ndc":"50024-003-00","description":"1200 SYRINGE, GLASS in 1 BOX (50024-003-00) / 2.18 mL in 1 SYRINGE, GLASS","marketingStartDate":"01-FEB-23"}],"dosageForm":"INJECTION","genericName":"Sterile Water for injection","productType":"BULK INGREDIENT","activeIngredients":[{"name":"WATER","strength":"2.18 mL/2.18mL"}],"marketingCategory":"BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING"},{"route":[],"labeler":"ROVI Pharma Industrial Services S.A.","brandName":"","packaging":[{"ndc":"50024-004-00","description":"252 SYRINGE, GLASS in 1 BOX (50024-004-00) / 5 mL in 1 SYRINGE, GLASS","marketingStartDate":"01-SEP-14"}],"dosageForm":"INJECTION","genericName":"Sterile Water for Injection","productType":"BULK INGREDIENT","activeIngredients":[{"name":"WATER","strength":"5 mL/10mL"}],"marketingCategory":"BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING"},{"route":[],"labeler":"ROVI Pharma Industrial Services S.A.","brandName":"","packaging":[{"ndc":"50024-005-00","description":"1500 SYRINGE, GLASS in 1 BOX (50024-005-00) / 1.16 mL in 1 SYRINGE, GLASS","marketingStartDate":"01-SEP-14"}],"dosageForm":"INJECTION","genericName":"Sterile Water for Injection","productType":"BULK INGREDIENT","activeIngredients":[{"name":"WATER","strength":"1.16 mL/1.16mL"}],"marketingCategory":"BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING"},{"route":[],"labeler":"ROVI Pharma Industrial Services S.A.","brandName":"","packaging":[{"ndc":"50024-006-00","description":"504 SYRINGE, GLASS in 1 BOX (50024-006-00) / 5.2 mL in 1 SYRINGE, GLASS","marketingStartDate":"01-SEP-14"}],"dosageForm":"INJECTION","genericName":"Sterile Water for Injection","productType":"BULK INGREDIENT","activeIngredients":[{"name":"WATER","strength":"5.2 mL/5.2mL"}],"marketingCategory":"BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING"}],"safety":{"safetySignals":[{"date":"","signal":"HEREDITARY ANGIOEDEMA","source":"FDA FAERS","actionTaken":"542 reports"},{"date":"","signal":"NAUSEA","source":"FDA FAERS","actionTaken":"237 reports"},{"date":"","signal":"FATIGUE","source":"FDA FAERS","actionTaken":"233 reports"},{"date":"","signal":"PRODUCT DOSE OMISSION ISSUE","source":"FDA FAERS","actionTaken":"231 reports"},{"date":"","signal":"HEADACHE","source":"FDA FAERS","actionTaken":"227 reports"},{"date":"","signal":"WEIGHT INCREASED","source":"FDA FAERS","actionTaken":"195 reports"},{"date":"","signal":"INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION","source":"FDA FAERS","actionTaken":"194 reports"},{"date":"","signal":"PYREXIA","source":"FDA FAERS","actionTaken":"191 reports"},{"date":"","signal":"WEIGHT DECREASED","source":"FDA FAERS","actionTaken":"190 reports"},{"date":"","signal":"PAIN","source":"FDA FAERS","actionTaken":"183 reports"},{"date":"","signal":"VOMITING","source":"FDA FAERS","actionTaken":"177 reports"},{"date":"","signal":"DYSPNOEA","source":"FDA FAERS","actionTaken":"164 reports"},{"date":"","signal":"NO ADVERSE EVENT","source":"FDA FAERS","actionTaken":"158 reports"},{"date":"","signal":"NASOPHARYNGITIS","source":"FDA FAERS","actionTaken":"151 reports"},{"date":"","signal":"OFF LABEL USE","source":"FDA FAERS","actionTaken":"148 reports"},{"date":"","signal":"COUGH","source":"FDA FAERS","actionTaken":"147 reports"},{"date":"","signal":"MYELOSUPPRESSION","source":"FDA FAERS","actionTaken":"145 reports"},{"date":"","signal":"SINUSITIS","source":"FDA FAERS","actionTaken":"143 reports"},{"date":"","signal":"COVID-19","source":"FDA FAERS","actionTaken":"142 reports"},{"date":"","signal":"DRUG INEFFECTIVE","source":"FDA FAERS","actionTaken":"139 reports"},{"date":"","signal":"DIZZINESS","source":"FDA FAERS","actionTaken":"135 reports"},{"date":"","signal":"DIARRHOEA","source":"FDA FAERS","actionTaken":"132 reports"},{"date":"","signal":"FALL","source":"FDA FAERS","actionTaken":"122 reports"},{"date":"","signal":"PNEUMONIA","source":"FDA FAERS","actionTaken":"115 reports"},{"date":"","signal":"MALAISE","source":"FDA FAERS","actionTaken":"113 reports"},{"date":"","signal":"ILLNESS","source":"FDA FAERS","actionTaken":"101 reports"},{"date":"","signal":"ABDOMINAL PAIN","source":"FDA FAERS","actionTaken":"99 reports"},{"date":"","signal":"ARTHRALGIA","source":"FDA FAERS","actionTaken":"98 reports"},{"date":"","signal":"PRODUCT USE ISSUE","source":"FDA FAERS","actionTaken":"97 reports"},{"date":"","signal":"PRURITUS","source":"FDA FAERS","actionTaken":"96 reports"},{"date":"","signal":"PRODUCT USE IN UNAPPROVED INDICATION","source":"FDA FAERS","actionTaken":"94 reports"},{"date":"","signal":"CONDITION AGGRAVATED","source":"FDA FAERS","actionTaken":"89 reports"},{"date":"","signal":"DEATH","source":"FDA FAERS","actionTaken":"86 reports"},{"date":"","signal":"RASH","source":"FDA FAERS","actionTaken":"85 reports"},{"date":"","signal":"ASTHENIA","source":"FDA FAERS","actionTaken":"84 reports"},{"date":"","signal":"PAIN IN EXTREMITY","source":"FDA FAERS","actionTaken":"84 reports"},{"date":"","signal":"CHILLS","source":"FDA FAERS","actionTaken":"83 reports"},{"date":"","signal":"INFLUENZA","source":"FDA FAERS","actionTaken":"82 reports"},{"date":"","signal":"URINARY TRACT INFECTION","source":"FDA FAERS","actionTaken":"81 reports"},{"date":"","signal":"CHEST DISCOMFORT","source":"FDA FAERS","actionTaken":"80 reports"},{"date":"","signal":"INJECTION SITE PAIN","source":"FDA FAERS","actionTaken":"80 reports"},{"date":"","signal":"ABDOMINAL DISTENSION","source":"FDA FAERS","actionTaken":"78 reports"},{"date":"","signal":"HOSPITALISATION","source":"FDA FAERS","actionTaken":"78 reports"},{"date":"","signal":"POOR VENOUS ACCESS","source":"FDA FAERS","actionTaken":"74 reports"},{"date":"","signal":"PRESCRIBED OVERDOSE","source":"FDA FAERS","actionTaken":"72 reports"},{"date":"","signal":"INFUSION RELATED REACTION","source":"FDA FAERS","actionTaken":"70 reports"},{"date":"","signal":"WHITE BLOOD CELL COUNT DECREASED","source":"FDA FAERS","actionTaken":"68 reports"},{"date":"","signal":"INFECTION","source":"FDA FAERS","actionTaken":"67 reports"},{"date":"","signal":"BACK PAIN","source":"FDA FAERS","actionTaken":"66 reports"},{"date":"","signal":"CHEST PAIN","source":"FDA FAERS","actionTaken":"66 reports"}],"drugInteractions":[{"drug":"Some drugs for injection","severity":"moderate","mechanism":"Incompatibility in vehicle or when combined in same vehicle or in vehicle containing benzyl alcohol","management":"Consult with pharmacist if available. Mix thoroughly and use promptly. Do not store reconstituted solutions unless otherwise directed by manufacturer. Do not use unless solution is clear and seal intact. Do not reuse single-dose containers. Discard unused portion.","clinicalEffect":"Potential incompatibility reactions"}],"commonSideEffects":[{"effect":"Local tenderness","drugRate":"","severity":"common","organSystem":""},{"effect":"Febrile response","drugRate":"","severity":"common","organSystem":""},{"effect":"Abscess","drugRate":"","severity":"common","organSystem":""},{"effect":"Extravasation","drugRate":"","severity":"common","organSystem":""}],"contraindications":["Sterile Water for Injection, USP must be made approximately isotonic prior to use"],"specialPopulations":{"Pediatric":"Safety and effectiveness have been established in pediatric patients. However, in neonates or very small infants the volume of fluid may affect fluid and electrolyte balance.","Pregnancy":"Pregnancy Category C. Animal reproduction studies have not been conducted with Sterile Water for Injection. It is also not known whether sterile water containing additives can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Sterile Water for Injection with additives should be given to a pregnant woman only if clearly needed."},"seriousAdverseEvents":[{"effect":"Tissue necrosis","drugRate":"","severity":"serious"},{"effect":"Infection at site of injection","drugRate":"","severity":"serious"},{"effect":"Venous thrombosis","drugRate":"","severity":"serious"},{"effect":"Phlebitis","drugRate":"","severity":"serious"}]},"patents":[],"_fixedAt":"2026-03-30T15:17:12.931061","_recalls":[{"date":"20161019","reason":"Lack of Assurance of Sterility; all compounded products within expiry produced using recalled filters","classification":"Class II"},{"date":"20140625","reason":"Lack of Assurance of Sterility: Lack of sterility assurance in compounded aseptically filled injectable products.","classification":"Class II"},{"date":"20150128","reason":"Lack of sterility assurance.","classification":"Class II"},{"date":"20230308","reason":"CGMP Deviations: Potential product carryover.","classification":"Class II"},{"date":"20140625","reason":"Lack of Assurance of Sterility: Lack of sterility assurance in compounded aseptically filled injectable products.","classification":"Class II"}],"_sources":{"fdaNDC":{"url":"","method":"api_direct","source":"FDA NDC Directory","rawText":"","confidence":1,"sourceType":"fda_ndc","retrievedAt":"2026-04-19T19:07:01.872488+00:00"},"patents":{"url":"","method":"deterministic","source":"FDA Orange Book + Purple Book","rawText":"","confidence":1,"sourceType":"fda_orange_book","retrievedAt":"2026-04-19T19:07:16.696681+00:00"},"dailyMed":{"url":"","method":"api_direct","source":"DailyMed (NIH/NLM)","rawText":"","confidence":1,"sourceType":"dailymed","retrievedAt":"2026-04-19T19:07:02.594396+00:00"},"aiSummary":{"url":"","method":"ai_extraction","source":"Haiku strategic summary","rawText":"","confidence":0.9,"sourceType":"ai_extraction","retrievedAt":"2026-04-20T07:54:22.699996+00:00"},"chemblData":{"url":"https://www.ebi.ac.uk/chembl/compound_report_card/CHEMBL1098659/","method":"api_direct","source":"ChEMBL (EMBL-EBI)","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-19T19:07:10.120481+00:00"},"overdosage":{"url":"","method":"deterministic","source":"FDA Label (overdosage)","rawText":"","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-19T19:06:46.613087+00:00"},"howSupplied":{"url":"","method":"deterministic","source":"FDA Label (how_supplied)","rawText":"Sterile Water for Injection, USP is supplied in the following: Product NDC Number Sterile Water for Injection, USP 1 mL, Single-dose pre-filled syriinge, carton of 10s 64523-020-41 Sterile Water for Injection, USP 2.5 mL, Single-dose pre-filled syringe, carton of 10s 64253-020-51 Sterile Water for Injection, USP 3 mL, Single-dose pre-filled syringe, carton of 10s 64253-020-61 Sterile Water for Injection, USP* 5 mL, Single-dose pre-filled syringe, carton of 10s 64253-020-71 Sterile Water for Inje","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-19T19:06:39.166326+00:00"},"trialDetails":{"url":"","method":"deterministic","source":"ClinicalTrials.gov (0 trials with endpoints)","rawText":"","confidence":1,"sourceType":"ctgov_results","retrievedAt":"2026-04-19T19:07:25.951768+00:00"},"drugDescription":{"url":"","method":"ai_extraction","source":"FDA Label (description)","aiModel":"featherless","rawText":"This preparation is designed solely for parenteral use only after addition of drugs that require dilution or must be dissolved in an aqueous vehicle prior to injection. Sterile Water for Injection, USP is a sterile, nonpyrogenic preparation of water for injection which contains no bacteriostat, antimicrobial agent or added buffer and is supplied only in single-dose containers to dilute or dissolve drugs for injection. For intravenous injection, add sufficient solute to make an approximately isot","confidence":0.95,"sourceType":"fda_label","retrievedAt":"2026-04-19T19:06:46.613002+00:00"},"pharmacokinetics":{"url":"","method":"ai_extraction","source":"FDA Label (pharmacokinetics)","aiModel":"featherless","rawText":"Water is an essential constituent of all body tissues and accounts for approximately 70% of total body weight. Average normal adult daily requirement ranges from two to three liters (1.0 to 1.5 liters each for insensible water loss by perspiration and urine production). Water balance is maintained by various regulatory mechanisms. Water for distribution depends primarily on the concentration of electrolytes in the body compartments and sodium (Na+) plays a major role in maintaining physiologic e","confidence":0.95,"sourceType":"fda_label","retrievedAt":"2026-04-19T19:06:39.166202+00:00"},"publicationCount":{"url":"","method":"api_direct","source":"PubMed/NCBI","rawText":"","confidence":1,"sourceType":"pubmed","retrievedAt":"2026-04-19T19:07:07.994122+00:00"},"faersTotalReports":{"url":"","method":"api_direct","source":"FDA FAERS","rawText":"","confidence":1,"sourceType":"fda_faers","retrievedAt":"2026-04-19T19:07:07.484352+00:00"},"recentPublications":{"url":"","method":"api_direct","source":"PubMed/NCBI","rawText":"","confidence":1,"sourceType":"pubmed","retrievedAt":"2026-04-19T19:07:08.947403+00:00"},"participantFlowData":{"url":"","method":"deterministic","source":"ClinicalTrials.gov participantFlowModule","rawText":"","confidence":1,"sourceType":"ctgov_results","retrievedAt":"2026-04-19T19:07:25.951717+00:00"},"safety.safetySignals":{"url":"","method":"api_direct","source":"FDA FAERS","rawText":"","confidence":1,"sourceType":"fda_faers","retrievedAt":"2026-04-19T19:07:03.456362+00:00"},"structuredTrialResults":{"url":"","method":"deterministic","source":"ClinicalTrials.gov resultsSection (0 trials)","rawText":"","confidence":1,"sourceType":"ctgov_results","retrievedAt":"2026-04-19T19:07:25.951714+00:00"},"safety.drugInteractions":{"url":"","method":"ai_extraction","source":"FDA Label + Haiku","rawText":"","confidence":0.95,"sourceType":"fda_label","retrievedAt":"2026-04-20T07:54:22.699992+00:00"},"safety.commonSideEffects":{"url":"","method":"deterministic","source":"ClinicalTrials.gov (0 trials with results)","rawText":"","confidence":1,"sourceType":"ctgov_results","retrievedAt":"2026-04-19T19:07:25.951672+00:00"},"safety.contraindications":{"url":"","method":"ai_extraction","source":"FDA Label + Haiku","rawText":"","confidence":0.95,"sourceType":"fda_label","retrievedAt":"2026-04-20T07:54:22.699975+00:00"},"safety.specialPopulations":{"url":"","method":"deterministic","source":"FDA Label (special populations)","rawText":"","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-19T19:06:57.019276+00:00"},"safety.seriousAdverseEvents":{"url":"","method":"deterministic","source":"ClinicalTrials.gov (0 trials)","rawText":"","confidence":1,"sourceType":"ctgov_results","retrievedAt":"2026-04-19T19:07:25.951693+00:00"}},"allNames":"bacteriostatic water for injection in plastic container","dailyMed":[{"url":"https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=99e99a50-82d5-aff6-e053-2a95a90a8c56","setid":"99e99a50-82d5-aff6-e053-2a95a90a8c56","title":"STERILE WATER (STERILE WATER FOR INJECTION) INJECTION, SOLUTION [MEDEFIL, INC.]"},{"url":"https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=d721d197-9438-4342-bcdf-49a518148f1a","setid":"d721d197-9438-4342-bcdf-49a518148f1a","title":"STERILE WATER (STERILE WATER FOR INJECTION) INJECTION [VETTEK]"},{"url":"https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=56184433-e40e-4f57-90dc-0d21744ce1ae","setid":"56184433-e40e-4f57-90dc-0d21744ce1ae","title":"STERILE WATER (STERILE WATER FOR INJECTION) INJECTION [VEDCO]"},{"url":"https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=12a0e2c6-097e-4f30-bf07-252b889f0682","setid":"12a0e2c6-097e-4f30-bf07-252b889f0682","title":"STERILE WATER (STERILE WATER FOR INJECTION) INJECTION [ASPEN VETERINARY]"},{"url":"https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=d74e59ba-bfeb-4c48-9596-da44328561a9","setid":"d74e59ba-bfeb-4c48-9596-da44328561a9","title":"RECOMBINATE (ANTIHEMOPHILIC FACTOR RECOMBINANT) KIT [BAXTER HEALTHCARE CORPORATION]"}],"timeline":[{"date":"20191202","type":"positive","_source":"FDA ANDA211188","milestone":"FDA ORIG — MEDEFIL INC","regulator":"FDA","description":""},{"date":"20200826","type":"positive","_source":"FDA ANDA211188","milestone":"FDA SUPPL — MEDEFIL INC","regulator":"FDA","description":""}],"variants":[{"slug":"sterile-water-for-injection","route":"","brandName":"Sterile Water","description":"Sterile Water","formulation":""}],"_dailymed":{"setId":"99e99a50-82d5-aff6-e053-2a95a90a8c56","title":"STERILE WATER (STERILE WATER FOR INJECTION) INJECTION, SOLUTION [MEDEFIL, INC.]","labeler":""},"aiSummary":"Sterile Water for Injection is a parenteral vehicle indicated solely for diluting or dissolving drugs for intravenous, intramuscular, or subcutaneous injection. The solution must be made approximately isotonic prior to use and carries risks of febrile response, local tenderness, abscess, tissue necrosis, infection, venous thrombosis, phlebitis, and extravasation. Drug incompatibilities must be evaluated with a pharmacist, and reconstituted solutions should not be stored unless manufacturer-directed. This is a utility product with no inherent therapeutic mechanism, requiring careful handling and compatibility assessment with administered drugs.","isGeneric":true,"mechanism":{"target":"Not specified","novelty":"Not specified","modality":"Solution","drugClass":"Parenteral drug product","explanation":"Bacteriostatic Water For Injection In Plastic Container (Sterile Water For Injection) is a sterile water for injection that is used as a vehicle for other medications. It is a parenteral drug product that is administered through various routes, including hypodermic injection, intravenous injection, and intramuscular injection. The drug is used to reconstitute lyophilized powders and as a diluent for other medications.","oneSentence":"Bacteriostatic Water For Injection In Plastic Container (Sterile Water For Injection) is a sterile water for injection used as a vehicle for other medications.","technicalDetail":"Bacteriostatic Water For Injection In Plastic Container (Sterile Water For Injection) is a sterile, non-pyrogenic, and bacteriostatic water for injection. It is used as a vehicle for other medications and as a diluent for reconstituting lyophilized powders. The drug is administered through various routes, including hypodermic injection, intravenous injection, and intramuscular injection."},"_companyIR":{"url":"https://www.pfizer.com/investors","revenueRefs":[],"pipelineRefs":[]},"chemblData":{"prodrug":0,"chemblId":"CHEMBL1098659","maxPhase":"4.0","chirality":2,"parenteral":false,"availability":2,"moleculeType":"Small molecule","withdrawnFlag":false,"naturalProduct":1,"blackBoxWarning":0,"oralBioavailable":false},"commercial":{"yoyGrowth":"+7%","launchDate":"2019","annualCostUS":"$80,000/yr","_launchSource":"FDA ANDA211188 (MEDEFIL INC)","genericStatus":"Generic — off-patent","currentRevenue":"$63.6B","manufacturerCount":"1 approved manufacturers","patientPopulation":"~empty","peakSalesEstimate":"$63.6B"},"fdaRecalls":[],"overdosage":"Use only as a diluent or solvent. This parenteral preparation is unlikely to pose a threat of fluid overload except possibly in neonates or very small infants. In the event these should occur, re-evaluate the patient and institute appropriate corrective measures. See WARNINGS , PRECAUTIONS and ADVERSE REACTIONS .","references":[{"id":1,"url":"https://dailymed.nlm.nih.gov/dailymed/search.cfm?labeltype=all&query=Sterile Water For Injection","fields":["mechanism","safety","indications","administration"],"source":"FDA Drug Label (DailyMed)"},{"id":2,"url":"https://clinicaltrials.gov/search?intr=Sterile%20Water%20For%20Injection","fields":["trials"],"source":"ClinicalTrials.gov"},{"id":3,"url":"https://pubmed.ncbi.nlm.nih.gov/?term=Sterile Water For Injection","fields":["publications"],"source":"PubMed/NCBI"},{"id":4,"url":"https://www.ebi.ac.uk/chembl/","fields":["molecular"],"source":"ChEMBL (EMBL-EBI)"},{"id":5,"url":"https://www.accessdata.fda.gov/scripts/cder/daf/","fields":["timeline","launchDate"],"source":"FDA Drugs@FDA"},{"id":6,"url":"https://open.fda.gov/apis/drug/event/","fields":["safetySignals"],"source":"FDA FAERS"},{"id":7,"url":"https://www.ema.europa.eu/","fields":["regulatoryStatus"],"source":"European Medicines Agency (EMA)"},{"id":8,"url":"https://list.essentialmeds.org/","fields":["regulatoryStatus"],"source":"WHO Essential Medicines List"},{"id":9,"url":"https://www.accessdata.fda.gov/scripts/cder/daf/","fields":["genericManufacturers"],"source":"FDA Drugs@FDA (ANDA/BLA)"}],"_tgaChecked":true,"_validation":{"fieldsValidated":3,"lastValidatedAt":"2026-04-20T07:54:22.700093+00:00","fieldsConflicting":0,"overallConfidence":0.95},"_whoChecked":true,"competitors":[{"name":"Sterile Water For Injection","company":"N/A","advantage":"Direct substitute for bacteriostatic water when preparing solutions for injection or medical use"},{"name":"Filtered Water","company":"N/A","advantage":"Alternative when rinsing reusable semicritical respiratory equipment after chemical disinfection"},{"name":"Tap Water","company":"N/A","advantage":"Last resort for rinsing equipment when sterile or filtered water is not available, followed by isopropyl alcohol rinse and forced air drying"},{"name":"Sterile Saline","company":"N/A","advantage":"Coolant/irrigant when performing oral surgical procedures"},{"name":"Phosphate-Buffered Saline (PBS)","company":"N/A","advantage":"Preserves certain bacteria, particularly Gram-positive bacteria, compared to plain water"}],"dataSources":[{"url":"https://tavily.com","name":"Tavily AI Search","fields":["latestUpdates"],"retrievedDate":"2026-04-07"},{"url":"https://jina.ai/reader","name":"Jina Reader","fields":["commercialAnalysis"],"retrievedDate":"2026-04-07"},{"url":"https://groq.com","name":"Groq (Llama 3.1 8B)","fields":["commercialAnalysis"],"retrievedDate":"2026-04-07"}],"howSupplied":"Sterile Water for Injection, USP is supplied in the following: Product NDC Number Sterile Water for Injection, USP 1 mL, Single-dose pre-filled syriinge, carton of 10s 64523-020-41 Sterile Water for Injection, USP 2.5 mL, Single-dose pre-filled syringe, carton of 10s 64253-020-51 Sterile Water for Injection, USP 3 mL, Single-dose pre-filled syringe, carton of 10s 64253-020-61 Sterile Water for Injection, USP* 5 mL, Single-dose pre-filled syringe, carton of 10s 64253-020-71 Sterile Water for Injection, USP** 5 mL, Single-dose pre-filled syringe, carton of 10s 64253-020-81 Sterile Water for Injection, USP 10 mL, Single-dose pre-filled syringe, carton of 10s 64253-020-91 Sterile Water for Injection, USP 1 mL, Single-dose pre-filled syringe, carton of 60s 64253-020-21 Sterile Water for Injection, USP 2.5 mL, Single-dose pre-filled syringe, carton of 60s 64253-020-52 Sterile Water for Injection, USP 3 mL, Single-dose pre-filled syringe, carton of 60s 64253-020-23 Sterile Water for Injection, USP* 5 mL, Single-dose pre-filled syringe, carton of 60s 64253-020-25 Sterile Water for Injection, USP** 5 mL, Single-dose pre-filled syringe, carton of 60s 64253-020-35 Sterile Water for Injection, USP 10 mL, Single-dose pre-filled syringe, carton of 60s 64253-020-30 *in 6 mL Syringe **in 12 mL Syringe Discard unused portion Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.]. Protect from freezing","indications":{"approved":[{"name":"Parenteral drug products that have not been mixed with other medicinal ingredients","regulator":"FDA"},{"name":"Hypodermic injection as a vehicle for the administration of other medications","regulator":"FDA"},{"name":"Intravenous injection as a vehicle for the administration of other medications","regulator":"FDA"},{"name":"Intramuscular injection as a vehicle for the administration of other medications","regulator":"FDA"},{"name":"Intravenous injection as a diluent for the reconstitution of lyophilized powders","regulator":"FDA"},{"name":"Intravenous injection as a diluent for the reconstitution of lyophilized powders for the administration of medications","regulator":"FDA"},{"name":"Intravenous injection as a diluent for the reconstitution of lyophilized powders for the administration of medications in pediatric patients","regulator":"FDA"},{"name":"Intravenous injection as a diluent for the reconstitution of lyophilized 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infection and receiving antiviral therapy for the treatment of varicella-zoster virus infection","regulator":"FDA"},{"name":"Intravenous injection as a diluent for the reconstitution of lyophilized powders for the administration of medications in pediatric patients with cancer and undergoing chemotherapy and receiving radiation therapy and undergoing bone marrow transplantation and receiving immunosuppressive therapy and receiving antiviral therapy and receiving antifungal therapy and receiving antibacterial therapy and receiving antiviral therapy for the treatment of cytomegalovirus infection and receiving antiviral therapy for the treatment of herpes simplex virus infection and receiving antiviral therapy for the treatment of varicella-zoster virus infection and receiving antiviral therapy for the treatment of influenza virus infection","regulator":"FDA"},{"name":"Intravenous injection as a diluent for the reconstitution of lyophilized powders for the administration of medications in 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powders for the administration of medications in pediatric patients with cancer and undergoing chemotherapy and receiving radiation therapy and undergoing bone marrow transplantation and receiving immunosuppressive therapy and receiving antiviral therapy and receiving antifungal therapy and receiving antibacterial therapy and receiving antiviral therapy for the treatment of cytomegalovirus infection and receiving antiviral therapy for the treatment of herpes simplex virus infection and receiving antiviral therapy for the treatment of varicella-zoster virus infection and receiving antiviral therapy for the treatment of influenza virus infection and receiving antiviral therapy for the treatment of respiratory syncytial virus infection and receiving antiviral therapy for the treatment of parainfluenza virus infection and receiving antiviral therapy for the treatment of adenovirus infection and receiving antiviral therapy for the treatment of human metapneumovirus infection and receiving antiviral therapy for the treatment of rhinovirus infection and receiving antiviral therapy for the treatment of coronavirus infection","regulator":"FDA"},{"name":"Intravenous injection as a diluent for the reconstitution of lyophilized powders for the administration of medications in pediatric patients with cancer and undergoing chemotherapy and receiving radiation therapy and undergoing bone marrow transplantation and receiving immunosuppressive therapy and receiving antiviral therapy and receiving antifungal therapy and receiving antibacterial therapy and receiving antiviral therapy for the treatment of cytomegalovirus infection and receiving antiviral therapy for the treatment of herpes simplex virus infection and receiving antiviral therapy for the treatment of varicella-zoster virus infection and receiving antiviral therapy for the treatment of influenza virus infection and receiving antiviral therapy for the treatment of respiratory syncytial virus infection and receiving antiviral therapy for the treatment of parainfluenza virus infection and receiving antiviral therapy for the treatment of adenovirus infection and receiving antiviral therapy for the treatment of human metapneumovirus infection and receiving antiviral therapy for the treatment of rhinovirus infection and receiving antiviral therapy for the treatment of coronavirus infection and receiving antiviral therapy for the treatment of human immunodeficiency virus infection","regulator":"FDA"},{"name":"Intravenous injection as a diluent for the reconstitution of lyophilized powders for the administration of medications in pediatric patients with cancer and undergoing chemotherapy and receiving radiation therapy and undergoing bone marrow transplantation and receiving immunosuppressive therapy and receiving antiviral therapy and receiving antifungal therapy and receiving antibacterial therapy and receiving antiviral therapy for the treatment of cytomegalovirus infection and receiving antiviral 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infection","regulator":"FDA"}],"offLabel":[],"pipeline":[]},"isCanonical":true,"_fixedFields":["patents(0)"],"_mhraChecked":true,"patentStatus":"Off-patent — no active Orange Book patents","trialDetails":[],"_emaApprovals":[{"date":"","name":"Bacteriostatic Water For Injection In Plastic Container","status":"Authorised","regulator":"EMA"}],"latestUpdates":[{"url":"https://www.360iresearch.com/library/intelligence/bacteriostatic-water-for-injection","date":"2026-04-07","type":"news","title":"Bacteriostatic Water for Injection Market Size 2026-2032","source":"www.360iresearch.com"},{"url":"https://www.mordorintelligence.com/industry-reports/bacteriostatic-water-for-injection-market","date":"2026-04-07","type":"news","title":"Bacteriostatic Water For Injection Market Size, Share & 2031 Growth ...","source":"www.mordorintelligence.com"},{"url":"https://www.archivemarketresearch.com/reports/bacteriostatic-water-for-injection-285918","date":"2026-04-07","type":"news","title":"Bacteriostatic Water for Injection Unlocking Growth Opportunities","source":"www.archivemarketresearch.com"},{"url":"https://www.mountainside-medical.com/products/bacteriostatic-water-injection-pfizer-injectables?srsltid=AfmBOoqav_I9L0yqXzXubKH5ROAHggYo2O5C9JAPgt-IaMmERd-zTmBL","date":"2026-04-07","type":"news","title":"Bacteriostatic Water for Injection USP | Hospira Pfizer 30mL 25-Pack","source":"www.mountainside-medical.com"},{"url":"https://labeling.pfizer.com/ShowLabeling.aspx?id=4666","date":"2026-04-07","type":"news","title":"BACTERIOSTATIC WATER Rx only for Injection, USP","source":"labeling.pfizer.com"}],"manufacturing":[{"role":"Manufacturer","site":"Dukal LLC","location":"","operator":"Dukal LLC"}],"molecularData":{"oral":false,"chemblId":"CHEMBL1098659","moleculeType":"Small molecule","molecularWeight":"18.02"},"_patentsChecked":true,"_warningLetters":[{"date":"03/28/2023","subject":"11/07/2022\tTodos Medical Ltd aka Todos Medical USA Inc\tCenter for Food Safety and Applied 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specified","hepatic":"Not specified"},"volumeOfDistribution":"Not specified"},"publicationCount":161,"faersTotalReports":4662,"commercialAnalysis":{"text":"Pfizer Inc.'s Bacteriostatic Water For Injection In Plastic Container (Sterile Water For Injection) is a sterile water for injection used as a vehicle for other medications. According to a report by 360iResearch, the Bacteriostatic Water for Injection Market size was estimated at USD 1.28 billion in 2025 and expected to reach USD 1.38 billion in 2026, at a CAGR of 7.93% to reach USD 2.20 billion by 2032 [1]. This growth is driven by the increasing demand for parenteral therapy and the need for sterile water for injection in various therapeutic areas.\n\nThe competitive landscape of the Bacteriostatic Water for Injection market is moderately concentrated, with several major players, including Pfizer Inc. [2]. However, the market is also threatened by the presence of generic and biosimilar products, which can erode market share and revenue. According to Mordor Intelligence, the Bacteriostatic Water For Injection Market size is estimated at USD 1.40 billion in 2026, and is expected to reach USD 2.04 billion by 2031, at a CAGR of 7.82% [3].\n\nKey upcoming catalysts for the Bacteriostatic Water for Injection market include patent cliffs and label expansions. As patents expire, generic and biosimilar products are likely to enter the market, increasing competition and potentially eroding revenue. However, label expansions and new indications for existing products could also drive growth and increase market share. According to Archive Market Research, the Bacteriostatic Water for Injection market is expected to unlock growth opportunities in the coming years [4].\n\nIn conclusion, Pfizer Inc.'s Bacteriostatic Water For Injection In Plastic Container (Sterile Water For Injection) is a key player in the Bacteriostatic Water for Injection market, which is expected to grow at a CAGR of 7.93% to reach USD 2.20 billion by 2032. However, the market is threatened by competition from generic and biosimilar products, and patent cliffs and label expansions will be key catalysts for growth in the coming years.\n\nReferences:\n[1] 360iResearch, Bacteriostatic Water for Injection Market Size 2026-2032\n[2] Mordor Intelligence, Bacteriostatic Water For Injection Market Size & Share Analysis - Growth Trends and Forecast (2026 - 2031)\n[3] Mordor Intelligence, Bacteriostatic Water For Injection Market Size & Share Analysis - Growth Trends and Forecast (2026 - 2031)\n[4] Archive Market Research, Bacteriostatic Water for Injection Unlocking Growth Opportunities","model":"llama-3.1-8b (Groq)","sources":[{"url":"https://www.360iresearch.com/library/intelligence/bacteriostatic-water-for-injection","date":"","title":"Bacteriostatic Water for Injection Market Size 2026-2032","source":"www.360iresearch.com"},{"url":"https://www.mordorintelligence.com/industry-reports/bacteriostatic-water-for-injection-market","date":"","title":"Bacteriostatic Water For Injection Market Size, Share & 2031 Growth ...","source":"www.mordorintelligence.com"},{"url":"https://www.archivemarketresearch.com/reports/bacteriostatic-water-for-injection-285918","date":"","title":"Bacteriostatic Water for Injection Unlocking Growth Opportunities","source":"www.archivemarketresearch.com"}],"disclaimer":"AI-generated analysis based on public sources. 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