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FDAOctober 12, 2021drug

Irbesartan Tablets USP, 300 mg a) 30 count (NDC 68180-412-06) and b) 90 count NDC# 68180-412-09) bottles, Rx only

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

The hazard

CGMP Deviations: impurity N-nitrosoirbesartan detected in API

What to do

FDA enforcement status: Terminated

Brands named

lupin pharmaceuticalslupin

Recall history

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

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