Enoxaparin Sodium Injection, USP, 40 mg/0.4 mL, Single-Dose Syringes with Automatic Safety Device...
FDA Recall #D-0286-2022 — Class I — November 17, 2021
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
Recalling Firm
Sandoz Inc — Princeton, NJ
Classification
Class I — Reasonable probability of serious adverse health consequences or death.
Product Type
Drugs
Product Quantity
45,036 cartons
Distribution
Nationwide in the US
Code Information
Lot #SAB06761A, exp 04/2023
Status
Completed
Voluntary / Mandated
Voluntary: Firm initiated