Appco Pharma LLC recalls Ranitidine Capsules 150 mg, (a) 60 count bottles (NDC 62559-690-60) , (b) 500 count bottles (NDC 62559-690-05), Rx only,
Recalled January 15, 2020 · FDA recall D-0649-2020 · Appco Pharma
Hazard
CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API · FDA Class II
Units
624 bottes
Sold at
Product was distributed to 6 major distributors/wholesalers some with multiple locations who may have further distribute the product.
Description
CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API
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.
Manufacturer(s)
Appco Pharma LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →