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
Reported: December 8, 2021 Initiated: November 17, 2021 #D-0286-2022
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
Reason for Recall
Temperature Abuse; temperature excursion during shipping
Details
- Recalling Firm
- Sandoz Inc
- Units Affected
- 45,036 cartons
- Distribution
- Nationwide in the US
- Location
- Princeton, NJ
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Sandoz Inc. Units affected: 45,036 cartons.
Why was this product recalled? ▼
Temperature Abuse; temperature excursion during shipping
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on December 8, 2021. Severity: Critical. Recall number: D-0286-2022.
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