Drug product
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
D-0286-2022
Product summary
- Firm
- Sandoz Inc
- Event
- Event 89033
- Status
- Completed
- Classification
- Class I
- Quantity
- 45,036 cartons
- Official record key
drug-enforcement:D-0286-2022
Official wording
Reason: Temperature Abuse; temperature excursion during shipping
Code information: Lot #SAB06761A, exp 04/2023
Distribution pattern: Nationwide in the US
Derived failure modes
-
Unknown
Temperature Abuse; temperature excursion during shipping