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| The United States: Hospira, Inc., Issues A Voluntary Nationwide Recall for one lot of BACTERIOSTATIC WATER for Injection, USP, due to a Potential Lack of Sterility Assurance (English only) |
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The US Food and Drug Administration (FDA) announces that Hospira, Inc., a Pfizer company, is voluntarily recalling BACTERIOSTATIC WATER for Injection, USP, 30 mL, multi-dose vial, lot W20308, to the Hospital/Retail level. Hospira initiated this recall due to lack of confirmation of sterilization for some vials from this lot.
BACTERIOSTATIC WATER for Injection, USP, 30 mL, multi-dose vial is a sterile, nonpyrogenic preparation of water for injection containing 0.9% (9 mg/mL) of benzyl alcohol added as a bacteriostatic preservative. It 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.
Hospira, Inc., places the utmost emphasis on patient safety and product quality at every step in the manufacturing and supply chain process. Hospira is notifying its direct customers via a recall letter to arrange for return of any recalled product.
Please refer to the following website in FDA for details:
http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/hospira-inc-issues-voluntary-nationwide-recall-one-lot-bacteriostatic-water-injection-usp-due
Local Situation in Hong Kong: In Hong Kong, the above product is not a registered pharmaceutical product.
Ends/ Saturday, 7 September, 2019
Issued at HKT 12:00
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