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
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
Lot numbers, UPCs & expiration codes
Lot #: 7S572, Exp. 04/2019
Where it was sold
Distributed nationwide.
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0153-2018
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Dec 5, 2017
- FDA report date
- Jan 17, 2018
- Quantity
- 11,474 cartons of 10 syringes per carton
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Sanofi-Aventis U.S. LLC
Original FDA data
Every field from FDA enforcement report D-0153-2018, exactly as published.
Show all FDA fields
- City
- Bridgewater
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 78637
- Address
- 55 Corporate Dr
- Code information
- Lot #: 7S572, Exp. 04/2019
- Postal code
- 08807-1265
- Report date
- Jan 17, 2018
- Product type
- Drugs
- Recall number
- D-0153-2018
- Classification
- Class III
- Recalling firm
- Sanofi-Aventis U.S. LLC
- Product quantity
- 11,474 cartons of 10 syringes per carton
- Termination date
- Oct 11, 2019
- 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
- Voluntary / mandated
- Voluntary: Firm initiated
- 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
- Distribution pattern
- Distributed nationwide.
- Recall initiation date
- Dec 5, 2017
- Initial firm notification
- Letter
- Center classification date
- Jan 5, 2018