FDA-Drug2018-01-17Class III
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
Sanofi-Aventis U.S. LLC
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
Sold states
Distributed nationwide.
Affected count
11,474 cartons of 10 syringes per carton
Manufactured in
55 Corporate Dr, N/A, Bridgewater, NJ, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0153-2018Don't want to check this manually?
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