FDA Drug · D-0797-2020

Preferred Pharmaceuticals, Inc, Ranitidine Tablets, 300 mg, Rx Only, a) 14 count bottles (NDC: 68788-6382-1), b) 30 count bottles (NDC: 68788-6382-3), c) 90 count bottles (NDC: 68788-6382-9), d) 100 count bottles (NDC: 68788-6382-0)

Class II · Terminated

CGMP Deviations: Presence of NDMA impurity detected in product.

Affected lots / codes — check yours against thisLot #: All lots within expiry

Recalling firm: Preferred Pharmaceuticals, Inc, Anaheim, CA
Classification: Class II (temporary or reversible harm possible)
Status: Terminated
Quantity: 39,172 tablets
Distribution: Distribution to physicians in the following states: AL, AZ, CA, FL, GA, IN, and SC
Recall initiated: January 7, 2020
Classified: January 20, 2020
Terminated: December 14, 2023
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-0797-2020%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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