Clinical Updates — Clinical Updates

FDA Alert: Hospira Recalls Vancomycin Hydrochloride

Recall prompted by uncontrolled storage during transit

The US Food and Drug Administration (FDA) has announced that Hospira, Inc. (Lake Forest, IL) has issued 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 an expiration date of 01 NOV 2015.

According to the FDA, the product may have experienced temperature excursions during shipment to a customer and then was further distributed by the customer. No adverse events or complaints have been reported for the affected lot.

If you have any inventory of the recalled lot, the FDA advises you to stop its use and distribution and quarantine the product immediately. Please notify all users in your facility. If you have further distributed the recalled product, please notify any additional locations that 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, the FDA and Hospira advise you to inform potential users of this product in your organization of this notification. Hospira will be notifying its direct customers via a recall letter and will arrange for the recalled product to be returned to Stericycle.

For additional assistance, call Stericycle at 1-844-861-6215 between 8:00 AM and 5:00 PM Eastern Time, Monday through Friday.

For details, please see the Hospira news release.

To report an adverse event or side effect:

  • Download the form or call 800-332-1088 to request the reporting form. Complete and return it to the address on the form, or fax to 800-FDA-0178. 

Updated October 8, 2014