Recall Enforment Report D-0153-2018
Drug Recall Enforcement Report Class III voluntary initiated by Sanofi-Aventis U.S. LLC, originally initiated on 12-05-2017 for 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 The product was recalled due to 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. The product was distributed nationwide and the recall is currently terminated.
Recalled Products
NDC | Proprietary Name | Non-Proprietary Name | Dosage Form | Route Name | Company Name | Product Type |
---|---|---|---|---|---|---|
0955-1003 | Enoxaparin Sodium | Enoxaparin Sodium | Injection | Subcutaneous | Winthrop U.s, A Business Of Sanofi-aventis U.s. Llc | Human Prescription Drug |
0955-1004 | Enoxaparin Sodium | Enoxaparin Sodium | Injection | Subcutaneous | Winthrop U.s, A Business Of Sanofi-aventis U.s. Llc | Human Prescription Drug |
0955-1006 | Enoxaparin Sodium | Enoxaparin Sodium | Injection | Subcutaneous | Winthrop U.s, A Business Of Sanofi-aventis U.s. Llc | Human Prescription Drug |
0955-1008 | Enoxaparin Sodium | Enoxaparin Sodium | Injection | Subcutaneous | Winthrop U.s, A Business Of Sanofi-aventis U.s. Llc | Human Prescription Drug |
0955-1010 | Enoxaparin Sodium | Enoxaparin Sodium | Injection | Subcutaneous | Winthrop U.s, A Business Of Sanofi-aventis U.s. Llc | Human Prescription Drug |
0955-1012 | Enoxaparin Sodium | Enoxaparin Sodium | Injection | Subcutaneous | Winthrop U.s, A Business Of Sanofi-aventis U.s. Llc | Human Prescription Drug |
0955-1015 | Enoxaparin Sodium | Enoxaparin Sodium | Injection | Subcutaneous | Winthrop U.s, A Business Of Sanofi-aventis U.s. Llc | Human Prescription Drug |
0955-1016 | Enoxaparin Sodium | Enoxaparin Sodium | Injection | Subcutaneous | Winthrop U.s, A Business Of Sanofi-aventis U.s. Llc | Human Prescription Drug |