Recalls / Class I
Class ID-0286-2022
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, 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
- Affected lot / code info
- Lot #SAB06761A, exp 04/2023
Why it was recalled
Temperature Abuse; temperature excursion during shipping
Recalling firm
- Firm
- Sandoz Inc
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 100 College Rd W, Princeton, New Jersey 08540-6604
Distribution
- Quantity
- 45,036 cartons
- Distribution pattern
- Nationwide in the US
Timeline
- Recall initiated
- 2021-11-17
- FDA classified
- 2021-12-16
- Posted by FDA
- 2021-12-08
- Status
- Completed
Source: openFDA Drug Enforcement endpoint. Recall record D-0286-2022. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.