Sandoz, Inc. Issues Nationwide Recall of 13 Lots of Orphenadrine Citrate 100 mg Extended Release Tablets Due to Presence of a Nitrosamine Impurity

Date: 03/22/2022

Product Type: Drugs, Impurity

Company Announcement Date: March 21, 2022

FDA Publish Date:  March 22, 2022

Product Type:  Drugs

Reason for Announcement: Presence of a Nitrosamine Impurity

Company Name: Sandoz, Inc.

Brand Name: Sandoz

Product Description: Orphenadrine Citrate 100 mg Extended Release (ER) Tablets

USA-FDA Link:  https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/sandoz-inc-issues-nationwide-recall-13-lots-orphenadrine-citrate-100-mg-extended-release-tablets-due