FDA Drug · D-0893-2022

Losartan Pot/HCTZ 100/12.5 mg 90 Tabs NDC 72189-290-90 Packaged and Distributed By: Direct Rx Dawsonville, GA 30534 Mfg. For Macleods Pharma USA, Inc. Plainsboro, NJ 08540

Class II · Terminated

CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits .

Affected lots / codes — check yours against thisLot: 25OC2116 Exp. 5/31/23

Recalling firm: Direct Rx, Dawsonville, GA
Classification: Class II (temporary or reversible harm possible)
Status: Terminated
Quantity: 11 bottles
Distribution: FL
Recall initiated: May 11, 2022
Classified: May 24, 2022
Terminated: December 2, 2022
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-0893-2022%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.

See every recall for this brand: Is LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE recalled? →

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