Hospira Recalls One Lot of Hydrochloride for Injection, USP
The company issues a voluntary nationwide recall due to the presence of particulate matter in a single vial.
On Jan. 24, 2017, Hospira, a Pfizer company, announced that it was voluntarily recalling one lot of Vancomycin Hydrochloride for Injection, USP to the hospital/retail level. The recall, which affects NDC: 0409-6510-01, Lot 591053A, Expiry Date 1NOV2017, is due to a customer report of particulate matter found in a vial. The affected lot was distributed in the United States from August 2016 through September 2016.
While Hospira had not received any reports of adverse events associated with the product at the time of the announcement, the company cautioned in a press release that administration of particulates may result in “local swelling, irritation of blood vessels or tissue, blockage of blood vessels and/or low-level allergic response to the particulate.” The company is advising customers to stop use and distribution of the recalled lot.
Vancomycin Hydrochloride is used to treat infections caused by susceptible strains of methicillin-resistant staphylococci. It may also be used by patients allergic to penicillin or who have not responded to other antimicrobials.
Source: FDA
Drug Shortages and Complying with FDA’s 21 CFR 211.110 Guidance
April 2nd 2025Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates, and Rona LeBlanc-Rivera, PhD, principal consultant, Regulatory Affairs at Regulatory Compliance Associates, answer some questions about FDA’s January 2025 21 CFR 211.110 guidance document.
AES Clean Technology Launches Next-Generation OSM Utility Solution for Cleanrooms at INTERPHEX 2025
April 2nd 2025Officially launched at INTERPHEX 2025, the Omni ASCENT is a next-generation off-site manufactured vertical utility solution that offers optimized cleanroom flexibility and efficiency.
