Apotex Corp. recalls Enoxaparin Sodium Injection, USP 100 mg/mL Single Dose Syringes with Automatic Safety Device For Subcutaneous Injection
Recalled February 17, 2021 · FDA recall D-0261-2021 · Apotex
Hazard
Labeling; Label Mixup; syringe barrels may containing markings for 150 mg/mL (corresponding to 120 mg/0.8mL strength) instead of 100 mg/mL markings (corresponding to 100 mg/mL strength) · FDA Class I
Units
6670 cartons
Sold at
Nationwide
Description
Labeling; Label Mixup; syringe barrels may containing markings for 150 mg/mL (corresponding to 120 mg/0.8mL strength) instead of 100 mg/mL markings (corresponding to 100 mg/mL strength)
Product
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)
Manufacturer(s)
Apotex Corp.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →