Ranitidine 150 mg tablets, 130 count bottles, NDC 37808-196-04.
Recall Number: D-0646-2020
Firm: AAA Pharmaceutical, Inc.
Classification: Class II
Status: Terminated
Report Date: 20200115
Initiation Date: 20191226
Termination Date: 20210310
Reason for Recall
CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API
Product Description
Ranitidine 150 mg tablets, 130 count bottles, NDC 37808-196-04.