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)
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)
Lot numbers, UPCs & expiration codes
Batch: CS008 Exp. 04/2022
Where it was sold
Nationwide
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0261-2021
- Classification
- Class I
- Status
- Ongoing
- Recall initiated
- Feb 2, 2021
- FDA report date
- Feb 17, 2021
- Quantity
- 6670 cartons
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Apotex Corp.
Original FDA data
Every field from FDA enforcement report D-0261-2021, exactly as published.
Show all FDA fields
- City
- Weston
- State
- FL
- Status
- Ongoing
- Country
- United States
- Event ID
- 87269
- Address
- 2400 N Commerce Pkwy Ste 400
- Code information
- Batch: CS008 Exp. 04/2022
- Postal code
- 33326-3253
- Report date
- Feb 17, 2021
- Product type
- Drugs
- Recall number
- D-0261-2021
- Classification
- Class I
- Recalling firm
- Apotex Corp.
- 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)
- Voluntary / mandated
- Voluntary: Firm initiated
- 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
- Recall initiation date
- Feb 2, 2021
- Initial firm notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Center classification date
- Feb 17, 2021