Orphenadrine Citrate Extended-Release Tablets, USP 100 mg, Rx Only, 100 Tablets, Manufactured by Sandoz Inc., Princeton, NJ 08540 NDC 0185-0022-01.
Recall Number: D-0753-2022
Firm: Sandoz, Inc
Classification: Class II
Status: Terminated
Report Date: 20220413
Initiation Date: 20220321
Termination Date: 20230814
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.