Sandoz, Inc: Drug Recall

Recall #D-0753-2022 · 03/21/2022

Class II: Risk

Recall Details

Recall Number: D-0753-2022
Classification: Class II
Product Type: Drug
Recalling Firm: Sandoz, Inc
Status: Terminated
Date Initiated: 03/21/2022
Location: Princeton, NJ, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 7908 bottles(790,800 extended release tablets)

Reason for Recall

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

Product Description

Orphenadrine Citrate Extended-Release Tablets, USP 100 mg, Rx Only, 100 Tablets, Manufactured by Sandoz Inc., Princeton, NJ 08540 NDC 0185-0022-01.

Distribution Pattern

Nationwide

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 I: Dangerous 11/17/2021

Temperature Abuse; temperature excursion during shipping

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.