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

FDA recall notice · announced January 17, 2018 · Sanofi-aventis U.s

Class III FDA/FSIS Class III: use is not likely to cause adverse health consequences.

The 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

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

Notes

Distribution: Distributed nationwide.
Lot/code information: Lot #: 7S572, Exp. 04/2019
Quantity: 11,474 cartons of 10 syringes per carton
Status: Terminated
Products in this recall event:
- 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 (D-0153-2018)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.