Drug product
Enoxaparin Sodium, Injection 120 mg/0.8 mL, pre-filled, packaged in 10-count cartons, Rx Only, Winthrop US., a business of Sanofi-aventis, U.S. LLC Bridgewater, NJ 08807, NDC 0955-1012-10
D-0153-2018
Product summary
- Event
- Event 78637
- Status
- Terminated
- Classification
- Class III
- Quantity
- 11,474 cartons of 10 syringes per carton
- Official record key
drug-enforcement:D-0153-2018
Official wording
Reason: Labeling: Label Error on Declared Strength. A single syringe labeled as 150 mg/1.0 mL was found packaged in a blister labeled as 120 mg/mL
Code information: Lot #: 7S572, Exp. 04/2019
Distribution pattern: Distributed nationwide.
Derived failure modes
-
Labeling or packaging
Labeling: Label Error