Yet ANOTHER recall for Hospira Hospira, Inc. (NYSE: HSP), announced it 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 01 NOV 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 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. This recall is being carried out to the medical facility/retail level (both human and veterinary). Please notify all users in your facility. If you have further distributed the recalled product please notify any accounts or additional locations which may have received the recalled product from you and instruct them if they have redistributed the product to notify their accounts, locations or facilities to the medical facility/retail level. In addition, customers should inform potential users of this product in their organizations of this notification. Hospira will be notifying its direct customers via a recall letter and will arrange for impacted product to be returned to Stericycle. For additional assistance, call Stericycle at 1-844-861-6215 between the hours of 8am to 5pm ET, Monday through Friday.
Posted on: Thu, 09 Oct 2014 05:02:14 +0000
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