January 19, 2018
Sanofi-Aventis US is recalling prefilled enoxaparin sodium injection, 120 mg/0.8 mL (NDC 0955-1012-10), after a syringe was found to contain 150 mg/1.0 mL rather than the labelled 120 mg/0.8 mL strength, according to the January 17, 2018, US Food and Drug Administration (FDA) Enforcement Report.
The recall affects 11,474 cartons, each containing 10 syringes, distributed nationwide from lot 7S572. The expiration date on the cartons is April 2019.
Sanofi-Aventis US voluntarily initiated the recall December 5, 2017. The FDA designated the recall Class III January 5, 2018, suggesting harm from using the injection is unlikely.
A type of heparin, enoxaparin is a prescription anticoagulant used to prevent or treat blood clots.
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