Hospira: Lack of sterilisation confirmation triggers voluntary recall of Bacteriostatic Water for Injection

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

Hospira has started a voluntarily recall, at hospital and retail level, of Bacteriostatic Water for Injection. The Pfizer company said the measure is due to lack of confirmation of sterilisation for some vials from this lot. The manufactured products under investigation are the USP, 30 mL, multi-dose vial, lot W20308.

In the event that impacted product is administered to a patient, there is an increased risk that severe adverse events, such as invasive bacterial infection, including bacterial meningitis, septicemia, and limited adverse events such as fever, chills, malaise, and cutaneous abscess may occur.

To date, Hospira has not received reports of any such adverse events associated with this issue for 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.

The product was distributed in the US and Puerto Rico to Hospitals/Retailers from March 2018 to April 2018.

"Hospira 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 the return of any recalled product," reads a statement.

The company said that anyone with an existing inventory of the recalled lot should stop use and distribution and quarantine immediately.

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