Product: Orphenadrine Citrate Extended-Release Tablets, USP 100 mg, Rx Only, 100 Tablets, Manufactured by Sandoz Inc., Princeton, NJ 08540 NDC 0185-0022-01.
Reason for recall: CGMP Deviations:Nitrosamine impurity (NMOA) above the acceptable daily limit.
Recall initiated: 20220321
Status: Terminated
Classification: Class II
Recall type: Voluntary: Firm initiated