Drug product
Sterile powder Vancomycin Hydrochloride for Injection, USP, Equivalent to 1 g in 25 ml fliptop vial, 10-count tray, Rx only, Manufactured by Hospira, Inc. Lake Forest, IL 60045, NDC 0409-6533-01.
D-0254-2015
Product summary
- Firm
- Hospira Inc.
- Event
- Event 69659
- Status
- Terminated
- Classification
- Class III
- Quantity
- 316,640 vials
- Official record key
drug-enforcement:D-0254-2015
Official wording
Reason: Correct Labeled Product Mispack: Product tray containing vials was mislabeled to contain another product.
Code information: Lot# 43-240-DD; Exp. 07/16 Lot# 44-205-DD,44-455-DD,44-460-DD,44-465-DD; Exp. 08/16
Distribution pattern: Nationwide.
Derived failure modes
-
Labeling or packaging
mislabeled