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.

FDA recall notice · announced January 15, 2020 · Appco Pharma

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

The product

Reason for recall

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

Notes

Distribution: Product was distributed to 6 major distributors/wholesalers some with multiple locations who may have further distribute the product.
Lot/code information: Batch # 1905227UE, exp. date Apr-2021 1905228UE, exp. date Apr-2021
Quantity: 1,632 bottes
Status: Terminated
Products in this recall event:
- 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 Ph (D-0649-2020)
- 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. (D-0648-2020)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.