Product: Ranitidine Capsules 150 mg, (a) 60 count bottles (NDC 62559-690-60) , (b) 500 count bottles (NDC 62559-690-05), Rx only, Manufactured by: Appco Pharma LLC, Piscataway, NJ 08854, Distributed by: ANI Pharmaceuticals, Inc., Baudette, MN 56623.
Reason for recall: CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API
Recall initiated: 20200107
Status: Terminated
Classification: Class II
Recall type: Voluntary: Firm initiated