Home / Recalls / Apotex Corp. / D-0262-2021

D-0262-2021 Class I Ongoing

Recalled by Apotex Corp. — Weston, FL

Recall Details

Product Type
Drugs
Report Date
February 17, 2021
Initiation Date
February 2, 2021
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
6832 cartons

Product Description

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)

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 Pattern

Nationwide

Code Information

Batch: CT003 Exp. 05/2022

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