Hospira Recalls Sterile Water for Injection

Hospira, a Pfizer company, announced on May 4, 2021 that it was voluntarily recalling lot DN9185 of Sterile Water for Injection, USP, 100 mL Single Dose Glass Fliptop Vial because of a report of visible particulate found in a single vial. Sterile Water for Injection USP is used to dilute or dissolve drugs for intravenous, intramuscular, or subcutaneous injection. The impacted lot was distributed nationwide from October through December 2020.

According to the company, use of the impacted product could cause rare instances of anaphylaxis, fever, gastrointestinal disturbances, vein irritation, localized vein inflammation, phlebitis, end-organ granuloma, tissue ischemia, pulmonary emboli, and infarction. As of the date of the press release, the company has not received reports of adverse events associated with the recalled lot. Adverse events may be reported to FDA’s MedWatch Adverse Event Reporting program.

Source: FDA