Recalls / Class III
Class IIID-0153-2018
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
- Brand name
- Enoxaparin Sodium
- Generic name
- Enoxaparin Sodium
- Active ingredient
- Enoxaparin Sodium
- Route
- Subcutaneous
- NDCs
- 0955-1004, 0955-1003, 0955-1006, 0955-1008, 0955-1010, 0955-1016, 0955-1012, 0955-1015
- FDA application
- NDA020164
- Affected lot / code info
- Lot #: 7S572, Exp. 04/2019
Why it was 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
Recalling firm
- Firm
- Sanofi-Aventis U.S. LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 55 Corporate Dr, N/A, Bridgewater, New Jersey 08807-1265
Distribution
- Quantity
- 11,474 cartons of 10 syringes per carton
- Distribution pattern
- Distributed nationwide.
Timeline
- Recall initiated
- 2017-12-05
- FDA classified
- 2018-01-05
- Posted by FDA
- 2018-01-17
- Terminated
- 2019-10-11
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0153-2018. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.