FDAMay 5, 2022drug

Losartan Pot./HCTZ 100/12.5 mg Packaged and Distributed By: Direct Rx Dawsonville, GA 30534 Mfg For: Lupin Pharmaceuticals, Inc. Baltimore, MD 21202 a) 30 Tabs NDC 72189-167-30; b) 90 Tabs NDC 72189-167-90

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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Losartan Pot./HCTZ 100/12.5 mg Packaged and Distributed By: Direct Rx Dawsonville, GA 30534 Mfg For: Lupin Pharmaceuticals, Inc. Baltimore, MD 21202 a) 30 Tabs NDC 72189-167-30; b) 90 Tabs NDC 72189-167-90 — Recall Details · AllClear