Drug & medication recalls

Lupin Pharmaceuticals, Inc. recalls Lupin — Irbesartan and Hydrochlorothiazide Tablets USP, 150mg/12.5 mg and 300mg/12.5 mg

Recall date
October 14, 2021
Source
U.S. Food & Drug Administration (FDA) — recall announcement
Brand / firm
Lupin Pharmaceuticals, Inc., Lupin

Why it was recalled

API batches above the specification limit for the impurity, N-nitrosoirbesartan — Impurity

What was recalled

Irbesartan and Hydrochlorothiazide Tablets USP, 150mg/12.5 mg and 300mg/12.5 mg

Read the official recall notice →

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More recalls from: Lupin Pharmaceuticals, Inc., Lupin