Sanofi-Aventis U.S. LLC recalls Enoxaparin Sodium, Injection 120 mg/0.8 mL, pre-filled, packaged in 10-count cartons, Rx Only, Winthrop US., a business
Recalled January 17, 2018 · FDA recall D-0153-2018 · Sanofi-Aventis U.S
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 · FDA Class III
Units
11,474 cartons of 10 syringes per carton
Sold at
Distributed nationwide.
Description
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
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
Manufacturer(s)
Sanofi-Aventis U.S. LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →