Medicine recalls
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| The United States: Vancomycin Hydrochloride for Injection, USP by Hospira: Recall - particulate matter in vial |
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The U.S. Food and Drug Administration (FDA) announced that Hospira, Inc. is voluntarily recalling one lot of Vancomycin Hydrochloride for Injection, USP (NDC: 0409-6510-01, Lot 591053A, Expiry Date 1NOV2017), to the hospital/retail level due to a confirmed customer report for the presence of particulate matter within a single vial. The product is packaged in a carton containing 1x100 mL vial. The lot was distributed from August 2016 through September 2016 in the United States.
Vancomycin Hydrochloride is indicated for the treatment of serious or severe infections caused by susceptible strains of methicillin-resistant staphylococci.
If particulate is administered to a patient, it 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 risk is reduced by the possibility of detection, as the label contains a clear statement directing the physician to visually inspect the product for particulate matter and discoloration prior to administration.
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/../ucm538219.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery
In Hong Kong, Vancomycin HCl for Inj 500mg IV (HK-33907) and 1g IV (HK-33908) are pharmaceutical products registered by Pfizer Corporation Hong Kong Limited (Pfizer HK). Both products are prescription only medicines and are manufactured by Hospira Inc. As confirmed with Pfizer HK, the affected lot in the U.S. FDA announcement has not been imported into Hong Kong.
Ends/ Thursday, January 26, 2017
Issued at HKT 14:00
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