Class III
Terminated
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
- Company
- Sanofi-Aventis U.S. Llc
- Recall Initiated
- December 5, 2017
- Posted
- January 17, 2018
- Recall Number
- D-0153-2018
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 11,474 cartons of 10 syringes per carton
- Firm Location
- Bridgewater, NJ, United States
Reason for Recall
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
Distribution
Distributed nationwide.
Lot / Code Info
Lot #: 7S572, Exp. 04/2019
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