FDA Drug · D-0016-2021

Ranitidine 150 mg, a) 60 Tabs (NDC 61919-339-60); and b) 90 Tabs (NDC 61919-339-90) bottles, Rx only, Packaged and Distributed By: Direct Rx Dawsonville, GA 30534

Class II · Terminated

CGMP Deviations: Presence of NDMA impurity detected in product.

Affected lots / codes — check yours against thisLots: a) 09AU1911 Exp. 02/28/2022; b) 09SE1904 Exp. 03/31/2022

Recalling firm: Direct Rx, Dawsonville, GA
Classification: Class II (temporary or reversible harm possible)
Status: Terminated
Quantity: a) 54 bottles; b) 26 bottles
Distribution: FL, GA
Recall initiated: January 15, 2020
Classified: October 5, 2020
Terminated: December 7, 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-0016-2021%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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