Apotex Corp.: Drug Recall

Recall #D-0261-2021 · 02/02/2021

Class I: Dangerous

Recall Details

Recall Number: D-0261-2021
Classification: Class I
Product Type: Drug
Recalling Firm: Apotex Corp.
Status: Ongoing
Date Initiated: 02/02/2021
Location: Weston, FL, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 6670 cartons

Reason for Recall

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 Description

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)

Distribution Pattern

Nationwide

Other Recalls by Apotex Corp.

Class II: Risk 09/05/2025

Lack of Assurance of Sterility; atypical weight loss due to improper bottle sealing leading to potential sterility concerns
Class II: Risk 09/05/2025

Lack of Assurance of Sterility; atypical weight loss due to improper bottle sealing leading to potential sterility concerns
Class II: Risk 05/28/2025

Lack of Assurance of Sterility
Class II: Risk 05/28/2025

Lack of Assurance of Sterility
Class II: Risk 05/28/2025

Defective Container: This recall is being initiated due to a leaking unit stored horizontally.

View all recalls by Apotex Corp. →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.