FDA Recall D-0286-2022
Sandoz Inc · Princeton, NJ
Class I — life-threatening Completed 1639 days on record
Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.
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
Reason for recall
Temperature Abuse; temperature excursion during shipping
Recall record
- Recall number
D-0286-2022- Classification
- Class I
- Status
- Completed
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Letter
- Distribution
- Nationwide in the US
- Recall initiated
- 2021-11-17
- Classified by FDA Center
- 2021-12-16
- FDA published
- 2021-12-08
- Recalling firm
- Sandoz Inc
- Firm location
- Princeton, NJ