Why it was recalled
Temperature Abuse; temperature excursion during shipping
Product description
Enoxaparin Sodium Injection, USP, 40 mg/0.4 mL, Single-Dose Syringes with Automatic Safety Device, For Subcutaneous Injection, Rx Only; 0.4 mL Syringes, Manufactured for Sandoz Inc., Princeton, NJ 08540, NDC 00781-3246-02; Carton (10 x 0.4 mL Syringes), Manufactured by Shenzhen Techdow Pharmaceutical Co., Ltd. Shenzhen City, Guangdong Province 518057, China for Sandoz Inc., Princeton, NJ 08540, NDC 00781-3246-64
Lot numbers, UPCs & expiration codes
Lot #SAB06761A, exp 04/2023
Where it was sold
Nationwide in the US
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-0286-2022
- Classification
- Class I
- Status
- Completed
- Recall initiated
- Nov 17, 2021
- FDA report date
- Dec 8, 2021
- Quantity
- 45,036 cartons
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Sandoz Inc
Original FDA data
Every field from FDA enforcement report D-0286-2022, exactly as published.
Show all FDA fields
- City
- Princeton
- State
- NJ
- Status
- Completed
- Country
- United States
- Event ID
- 89033
- Address
- 100 College Rd W
- Code information
- Lot #SAB06761A, exp 04/2023
- Postal code
- 08540-6604
- Report date
- Dec 8, 2021
- Product type
- Drugs
- Recall number
- D-0286-2022
- Classification
- Class I
- Recalling firm
- Sandoz Inc
- Product quantity
- 45,036 cartons
- Reason for recall
- Temperature Abuse; temperature excursion during shipping
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Enoxaparin Sodium Injection, USP, 40 mg/0.4 mL, Single-Dose Syringes with Automatic Safety Device, For Subcutaneous Injection, Rx Only; 0.4 mL Syringes, Manufactured for Sandoz Inc., Princeton, NJ 08540, NDC 00781-3246-02; Carton (10 x 0.4 mL Syringes), Manufactured by Shenzhen Techdow Pharmaceutical Co., Ltd. Shenzhen City, Guangdong Province 518057, China for Sandoz Inc., Princeton, NJ 08540, NDC 00781-3246-64
- Distribution pattern
- Nationwide in the US
- Recall initiation date
- Nov 17, 2021
- Initial firm notification
- Letter
- Center classification date
- Dec 16, 2021