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.

Recall Number: D-0649-2020

Firm: Appco Pharma LLC

Classification: Class II

Status: Terminated

Report Date: 20200115

Initiation Date: 20200107

Termination Date: 20200424

CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API

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.