Appco Pharma LLC recalls Ranitidine Capsules 300 mg, 30 count bottles. Rx only, Manufactured by: Appco Pharma LLC, Piscataway, NJ 08854, Distribu
Recalled January 15, 2020 · FDA recall D-0648-2020 · Appco Pharma
Hazard
CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API · FDA Class II
Units
1,632 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 300 mg, 30 count bottles. Rx only, Manufactured by: Appco Pharma LLC, Piscataway, NJ 08854, Distributed by: ANI Pharmaceuticals, Inc., Baudette, MN 56623, NDC 62559-691-30.
Manufacturer(s)
Appco Pharma LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →