FDA-Drug2020-01-15Class II
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.
Appco Pharma LLC
Hazard
CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API
Sold states
Product was distributed to 6 major distributors/wholesalers some with multiple locations who may have further distribute the product.
Affected count
624 bottes
Manufactured in
262 Old New Brunswick Rd Unit N, N/A, Piscataway, NJ, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0649-2020Don't want to check this manually?
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