FDAFDA · Food and drugs·Recall number D-0153-2018
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
Published January 17, 2018 · Recall initiated: December 5, 2017
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- ENOXAPARIN SODIUM
- Manufacturer
- Sanofi-Aventis U.S. LLC
- Distributor
- Distributed nationwide.
- Lot
- Lot #: 7S572, Exp. 04/2019
- Risk classification
- Class III
- Area (FDA)
- drug
- Country
- United States
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