Sandoz Inc: Drug Recall

Recall #D-0286-2022 · 11/17/2021

Class I: Dangerous

Recall Details

Recall Number: D-0286-2022
Classification: Class I
Product Type: Drug
Recalling Firm: Sandoz Inc
Status: Completed
Date Initiated: 11/17/2021
Location: Princeton, NJ, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 45,036 cartons

Reason for Recall

Temperature Abuse; temperature excursion during shipping

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

Distribution Pattern

Nationwide in the US

Other Recalls by Sandoz Inc

Class II: Risk 09/05/2025

cGMP deviations: Temperature excursion during transportation.
Class II: Risk 08/13/2025

Temperature Abuse
Class I: Dangerous 06/27/2025

Labeling: Label Mix-Up; cartons of Cefazolin for Injection, USP 1 gram were found to contain vials labeled as penicillin G potassium for Injection, USP, 20 million Unit. The vials contained Cefozalin
Class I: Dangerous 06/27/2025

Labeling: Label Mix-Up; Some vials of Cefazolin for Injection, USP 1 gram were incorrectly labeled as penicillin G potassium for Injection, USP, 20 million Unit
Class II: Risk 03/21/2022

CGMP Deviations:Nitrosamine impurity (NMOA) above the acceptable daily limit.

View all recalls by Sandoz Inc →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.