FDA-Drug2020-01-15Class II
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.
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
1,632 bottes
Manufactured in
262 Old New Brunswick Rd Unit N, N/A, Piscataway, NJ, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0648-2020Don't want to check this manually?
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