Hospira Voluntarily Recalls One Lot of Vancomycin HydrochlorideBy
Hospira, Inc. is initiating a voluntary nationwide user-level recall of one lot of vancomycin hydrochloride for injection, USP, equivalent to
1 g vancomycin (sterile powder), NDC 0409-6533-01, Lot 35-315-DD with expiration date of November 1, 2015. This action is because the product may have experienced temperature excursions during shipment to a customer and then was further distributed by the customer. There have been no adverse events or complaints reported for the affected lot. Hospira is undertaking the recall out of what the company terms an “abundance of caution.”
Due to lack of information on the effect of uncontrolled temperatures on vancomycin and toxicological and clinical characterization of potential degradants, a meaningful medical risk assessment cannot be performed.
This recall is being carried out to the medical facility/retail level (both human and veterinary).
Source: FDA and Hospira