Ranitidine Tablets, USP 150 mg, OTC, a.) 30 count bottle (NDC 68788-7078-03), b.) 60 count bottle (NDC 68788-7078-06), Mfg: Amneal Pharmaceuticals
Recall Number: D-0617-2020
Firm: Preferred Pharmaceuticals, Inc
Classification: Class II
Status: Terminated
Report Date: 20191218
Initiation Date: 20191202
Termination Date: 20230509
Reason for Recall
CGMP Deviations: Presence of NDMA impurity detected in product.
Product Description
Ranitidine Tablets, USP 150 mg, OTC, a.) 30 count bottle (NDC 68788-7078-03), b.) 60 count bottle (NDC 68788-7078-06), Mfg: Amneal Pharmaceuticals