Reported Nov 10, 2021 · Terminated

Irbesartan and Hydrochlorothiazide Tablets USP, 300/12.5 mg a) 30 count (NDC 68180-414-06) and b) 90 count (NDC…

Lupin Pharmaceuticals Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Lupin Pharmaceuticals Inc. · Harborplace Tower · Baltimore, MD · 21202-6174

Irbesartan and Hydrochlorothiazide Tablets USP, 300/12.5 mg a) 30 count (NDC 68180-414-06) and b) 90 count (NDC 68180-414-09) bottles, Rx only

Lot codes and dates: a) Lot# H804192
exp. date 31/08/2021 H805348
exp. date 30/11/2021 H900065
exp. date 31/12/2021 H902264
exp. date 31/05/2022 b) Lot# H804082
exp. date 31/08/2021 H804121
exp. date 31/08/2021 H804338
exp. date 31/08/2021 H804538
exp. date 30/09/2021 H804539
exp. date 30/09/2021 H805349
exp. date 30/11/2021 H805350
exp. date 30/11/2021 H900066
exp. date 31/12/2021 H900067
exp. date 31/12/2021 H902265
exp. date31/05/2022 H902275
exp. date31/05/2022 H902276
exp. date31/05/2022 H902531
exp. date 30/04/2022 H902532
exp. date 30/04/2022
Amount recalled: 98,052 bottles

The agency filed one notice per product. You are reading one of them; the other 4 are below.

CGMP Deviations: impurity N-nitrosoirbesartan detected in API

This product could cause temporary or reversible health problems — stop using it.

The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

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