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FDAMarch 31, 2022drug

Losartan Potassium and Hydrochlorothiazide Tablets USP, 100 mg/25 mg a) 30-count bottles (NDC# 68180-217-06) b) 90-count bottles (NDC# 68180-217-09), Rx Only, Manufactured By: Lupin Limited, Pithampur, India, MFG For: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202, USA

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

lupin pharmaceuticalslupin

UPCs

20226818021706202368180217062022681802170920236818021709

Recall history

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

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