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
Market Demands and Emerging Technologies Shape Outsourcing Models
June 5th 2025Trends in certain forms of drug delivery, as well as the emergence of artificial intelligence, are playing roles in evolving the nature of partnerships, but there are new types of partnerships gaining steam as well.
Guidance on Quality Culture Standards
June 3rd 2025Matt Cushing, VP of Quality and Science, Nelson Labs, and Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates, a Nelson Labs Company, discuss PDA/ANSI Standard 06-2025: Assessment of Quality Culture Guidance Documents, Models, and Tools, which was published in February 2025.