Reported Jan 17, 2018 · Terminated
Enoxaparin Sodium, Injection 120 mg/0.8 mL, pre-filled, packaged in 10-count cartons, Rx Only, Winthrop US., a business…
Sanofi-Aventis U.S. LLC
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Sanofi-Aventis U.S. LLC · 55 Corporate Dr · Bridgewater, NJ · 08807-1265
Is this the product you have?
- 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 codes and dates
Lot #: 7S572Exp. 04/2019
- Amount recalled
- 11,474 cartons of 10 syringes per carton
Where it was sold
- Nationwide
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
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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