Ranitidine Tablets, USP 300 mg, 250-count bottles, NDC 53746-254-02.
Recall Number: D-0616-2020
Firm: Amneal Pharmaceuticals, Inc.
Classification: Class II
Status: Ongoing
Report Date: 20191218
Initiation Date: 20191122
Termination Date:
Reason for Recall
CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API
Product Description
Ranitidine Tablets, USP 300 mg, 250-count bottles, NDC 53746-254-02.