Class I
Ongoing
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)
This recall is currently active, issued February 17, 2021. It was issued by Apotex Corp..
- Company
- Apotex Corp.
- Recall Initiated
- February 2, 2021
- Posted
- February 17, 2021
- Recall Number
- D-0262-2021
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 6832 cartons
- Firm Location
- Weston, FL, United States
- Official Source
- View on FDA website ↗
Reason for Recall
Labeling; Label Mixup; syringe barrels may contain markings for 100 mg/mL (corresponding to 100 mg/mL strength) instead of 150 mg/mL (corresponding to 120 mg/0.8mL strength)
Distribution
Nationwide
Lot / Code Info
Batch: CT003 Exp. 05/2022
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