FDAMay 11, 2022drug

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

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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

What to do

FDA enforcement status: Terminated

Brands named

direct rxdirect

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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