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
Reported: January 17, 2018 Initiated: December 5, 2017 #D-0153-2018
Product Description
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
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
Details
- Recalling Firm
- Sanofi-Aventis U.S. LLC
- Units Affected
- 11,474 cartons of 10 syringes per carton
- Distribution
- Distributed nationwide.
- Location
- Bridgewater, NJ
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Sanofi-Aventis U.S. LLC. Units affected: 11,474 cartons of 10 syringes per carton.
Why was this product recalled? ▼
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
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on January 17, 2018. Severity: Low. Recall number: D-0153-2018.
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