FDA Recall Enoxaparin Sodium
View Recall Number, Date, Reasons, Quantity
FDA Recall Enforcement Reports
The last Recall Enforcement Report for Enoxaparin Sodium with NDC 60505-0798 was initiated on 03-15-2021 as a Class II recall due to cgmp deviations: intermittent exposure to temperature excursion during storage. The latest recall number for this product is D-0426-2021 and the recall is currently completed .
| Recall Number | Initiation Date | Report Date | Recall Classification | Product Quantity | Product Description | Status |
|---|---|---|---|---|---|---|
| D-0426-2021 | 03-15-2021 | 06-02-2021 | Class II | 64 BOXES | ENOXAPARIN DOFIUM INJRVYION, UPD 150MG/1ML 10X1ML SINGLE DOSE SYRINGES; NDC/UPC 60505-0798-4; RX; SYRINGES | Completed |
| D-0262-2021 | 02-02-2021 | 02-17-2021 | Class I | 6832 cartons | Enoxaparin Sodium Injection, USP 120 mg/ 0.8 mL Single Dose Syringes with Automatic Safety Device For Subcutaneous Injection 10 x 0.8 mL Single Dose Syringes Rx Only,Manufactured by: Gland Pharma Ltd. Hyderabad, India Manufactured for: Apotex Corp. Weston, FL 33326 NDC 60505-0796-4 UPC 360505079543 (carton) NDC 60505-0796-0 UPC (01)10360505079602 (label) | Ongoing |
| D-0261-2021 | 02-02-2021 | 02-17-2021 | Class I | 6670 cartons | Enoxaparin Sodium Injection, USP 100 mg/mL Single Dose Syringes with Automatic Safety Device For Subcutaneous Injection 10 x 1 mL Single Dose Syringes Rx Only, Manufactured by: Gland Pharma Ltd. Hyderabad, India Manufactured for: Apotex Corp. Weston, FL 33326 NDC 60505-0795-4 UPC 360505079544 (carton) NDC 60505-0795-1 UPC (01)10360505079510 (label) | Ongoing |
What is the Enforcement Report?
All drug recalls are monitored by the Food and Drug Administration (FDA) and are included in the Enforcement Report once they are properly classified. The FDA will determine if a firm's removal or correction actions of a marked product meet the requirements to be considered a "recall". The FDA will also determine the public hazard assessment and a recall classification will be published in the Enforcement Report.