Hospira Recalls Product Due to Sterilization Concerns

September 11, 2019

The company is voluntarily recalling BACTERIOSTATIC WATER for Injection, USP, 30 mL, multi-dose vial, lot W20308, to the hospital/retail level because of a lack of confirmation of sterilization for some vials from this lot.

Hospira, a Pfizer company, announced on Sept. 6, 2019 that it was voluntarily recalling BACTERIOSTATIC WATER for Injection, USP, 30 mL, multi-dose vial, lot W20308, to the hospital/retail level. The recall was initiated because sterilization could not be confirmed for some vials in the lot.

According to the company, BACTERIOSTATIC WATER for Injection, USP, 30 mL, multi-dose vial is used for diluting or dissolving drugs for intravenous, intramuscular, or subcutaneous injection. It is a sterile, nonpyrogenic preparation of water for injection containing 0.9% (9 mg/mL) of benzyl alcohol added as a bacteriostatic preservative. There is a risk of bacterial infection if non-sterile product is administered to the patient.

The recalled product was distributed in the United States and Puerto Rico to hospitals and retailers from March–April 2018. The company has not received any reports of adverse events associated with the recall as of the September 6. Adverse events may be reported to FDA via its MedWatch program.

Source: FDA