Hospira Bacteriostatic Water for Injection, USP — Product Description
Hospira Bacteriostatic Water for Injection, USP is a sterile, nonpyrogenic preparation of water for injection containing 0.9% benzyl alcohol added as a bacteriostatic preservative . Manufactured by Hospira, Inc. (a Pfizer company), this product is designed exclusively for use as a diluent or solvent for medications that require reconstitution prior to parenteral administration .
Product Overview
| Property | Detail |
|---|---|
| Product Name | Bacteriostatic Water for Injection, USP |
| Manufacturer | Hospira, Inc. (a Pfizer company) |
| NDC | 0409-3977-03 (30 mL plastic fliptop vials) |
| Volume | 30 mL multiple-dose vial |
| Preservative | 0.9% (9 mg/mL) benzyl alcohol |
| pH | 5.7 (range 4.5–7.0) |
| Container | Semi-rigid plastic vial (polyolefin copolymer) |
| Storage | Store at 20–25°C (68–77°F); Do not refrigerate |
Indications and Usage
Hospira Bacteriostatic Water is indicated only for diluting or dissolving drugs for intravenous, intramuscular, or subcutaneous injection, according to the instructions of the medication manufacturer . It is not intended for direct injection as a fluid replacement or for any other therapeutic purpose .
The multiple-dose container design allows for repeated withdrawals using aseptic technique, making it suitable for healthcare settings where multiple reconstitutions are required .
Critical Safety Information
Warning: NOT FOR USE IN NEONATES
Benzyl alcohol, the preservative in this product, has been associated with toxicity in neonates, including a potentially fatal condition known as “gasping syndrome” characterized by central nervous system depression, metabolic acidosis, and cardiovascular failure . Solutions containing benzyl alcohol must not be used in neonates. Where water is required for preparing medications for neonates, only preservative-free Sterile Water for Injection should be used .
Contraindications
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Neonates: Due to benzyl alcohol toxicity risk
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Fluid replacement: Parenteral preparations with benzyl alcohol should not be used for fluid replacement
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Epidural or spinal anesthesia procedures: Benzyl alcohol-containing preparations are contraindicated
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Hypersensitivity: To benzyl alcohol
Important Warnings
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Intravenous administration without a solute may result in hemolysis
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Must be made approximately isotonic prior to use
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Do not exceed 30 mL per day of 0.9% benzyl alcohol-containing preparations in adults
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Consult the medication manufacturer’s instructions for proper dilution volumes and compatibility
Handling and Storage
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Store at controlled room temperature 20–25°C (68–77°F)
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Do not refrigerate
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Do not use unless the solution is clear and the seal is intact
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Use aseptic technique for all entries and withdrawals
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Do not store reconstituted drug solutions unless directed by the medication manufacturer
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Inspect reconstituted medications for clarity and freedom from precipitation before administration
Product Recalls and Quality Alerts
Hospira issued a voluntary nationwide recall in 2019 for one lot of Bacteriostatic Water for Injection, USP, 30 mL multiple-dose vials (Lot W20308, expiration December 2019) due to a potential lack of sterility assurance . The recall was initiated because sterilization could not be confirmed for some vials in that specific lot. Healthcare professionals and patients should verify their product lot numbers against FDA recall notices before use .
Frequently Asked Questions
Q: What is Hospira Bacteriostatic Water used for?
A: It is used exclusively as a diluent or solvent to reconstitute powdered medications for injection. It is not intended for direct therapeutic use .
Q: What is the difference between Bacteriostatic Water and Sterile Water for Injection?
A: Bacteriostatic Water contains 0.9% benzyl alcohol as a preservative, allowing multiple withdrawals from the same vial. Sterile Water for Injection contains no preservative and is intended for single use .
Q: Can Hospira Bacteriostatic Water be used for neonates?
A: No. It is contraindicated in neonates due to the risk of benzyl alcohol toxicity, which can cause “gasping syndrome” and other serious adverse effects .
Q: How should Hospira Bacteriostatic Water be stored?
A: Store at controlled room temperature 20–25°C (68–77°F). Do not refrigerate .
Q: Is Hospira Bacteriostatic Water FDA-approved?
A: Yes. This product is marketed under NDA 018802 and is listed in the FDA’s National Drug Code Directory .
Summary
Hospira Bacteriostatic Water for Injection, USP is a trusted, FDA-approved diluent containing 0.9% benzyl alcohol as a preservative. It is designed for reconstituting injectable medications in multiple-dose settings. Key safety considerations include its contraindication in neonates and the requirement for isotonic admixture before intravenous use. Healthcare professionals should always verify product lot numbers against FDA recall notices and follow aseptic technique during handling.
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