AUDIENCE: Pharmacy, Nursing, Health Professional
ISSUE:
Hospira, Inc. 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
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).
BACKGROUND: There have been no adverse events or complaints reported for the affected lot.
RECOMMENDATION:
Anyone with an existing inventory of the recalled lot should stop 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 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.
Healthcare
professionals and patients are encouraged to report adverse events or
side effects related to the use of these products to the FDA's MedWatch
Safety Information and Adverse Event Reporting Program:
- Complete and submit the report Online: www.fda.gov/MedWatch/report.
htm - Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
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