Medicine recalls
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| The United States: Vancomycin Hydrochloride for Injection USP, Equivalent to 1 Gram Vancomycin (Sterile Powder) by Hospira, Inc.: Recall - Uncontrolled Storage During Transit |
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The US Food and Drug Administration (FDA) announced that 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) (Lot 35-315-DD with expiration date of 01 NOV 2015). The product may have experienced temperature excursions during shipment to a customer and then was further distributed by the customer. This recall is being carried out to the medical facility/retail level (both human and veterinary). There have been no adverse events or complaints reported for the affected lot. Hospira is undertaking the recall out of 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. Anyone with an existing inventory of the recalled lot should stop use and distribution and quarantine the product immediately.
Please refer to the following website in FDA for details:
http://www.fda.gov/Safety/MedWatch/../ucm418065.htm
In Hong Kong, the concerned product Vancomycin HCL for Injection 1G IV (Hospira) (HK-33908) is registered by Hospira Limited (Hospira) and is a prescription-only medicine. Hospira confirmed that the concerned product has not been imported into or distributed in Hong Kong for the last two years, and the affected lot has not been imported into Hong Kong.
Ends/ Thursday, October 09, 2014
Issued at HKT 15:00
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