Recalls / Class I

Class ID-0261-2021

Class I— FDA's most serious classification, issued when there is a reasonable probability that use of or exposure to the drug will cause serious adverse health consequences or death.

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)

Affected lot / code info: Batch: CS008 Exp. 04/2022

Why it was recalled

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)

Recalling firm

Firm: Apotex Corp.
Notification channel: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Type: Voluntary: Firm initiated
Address: 2400 N Commerce Pkwy Ste 400, N/A, Weston, Florida 33326-3253

Distribution

Quantity: 6670 cartons
Distribution pattern: Nationwide

Timeline

Recall initiated: 2021-02-02
FDA classified: 2021-02-17
Posted by FDA: 2021-02-17
Status: Ongoing

Source: openFDA Drug Enforcement endpoint. Recall record D-0261-2021. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.