FDA Drug · D-0648-2020

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.

Class II · Terminated

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

Affected lots / codes — check yours against thisBatch # 1905227UE, exp. date Apr-2021 1905228UE, exp. date Apr-2021

Recalling firm: Appco Pharma LLC, Piscataway, NJ
Classification: Class II (temporary or reversible harm possible)
Status: Terminated
Quantity: 1,632 bottes
Distribution: Product was distributed to 6 major distributors/wholesalers some with multiple locations who may have further distribute the product.
Recall initiated: January 7, 2020
Classified: January 7, 2020
Terminated: April 24, 2020
Initiation: Voluntary: Firm initiated

Official source. This record is published by the U.S. FDA through the openFDA enforcement database. View the unmodified government record:
https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0648-2020%22

Important. Recalls target specific lots and codes — compare the affected lots above against your own product. This page reproduces public FDA data for readability; EveryRecall is independent and not affiliated with the FDA.

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