Reported Nov 10, 2021 · Terminated
Irbesartan and Hydrochlorothiazide Tablets USP, 150/12.5 mg a) 30 count (NDC 68180-413-06) 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
Is this the product you have?
- Irbesartan and Hydrochlorothiazide Tablets USP, 150/12.5 mg a) 30 count (NDC 68180-413-06) and b) 90 count (NDC 68180-413-09) bottles, Rx only
- Lot codes and dates
a) Lot# H804537exp. date 30/09/2021 H805148exp. date 31/10/2021 H900063exp. date 31/10/2021 H900522exp. date 31/12/2021 H901582exp. date 31/01/2022 b) Lot# H000963exp. date 30/04/2022 H804507exp. date 30/04/2022 H804536exp. date 30/09/2021 H805070exp. date 31/10/2021 H805149exp. date 31/10/2021 H900064exp. date 31/12/2021 H900523exp. date 31/01/2022 H901583exp. date 30/04/2022 H902530exp. date 30/04/2022
- Amount recalled
- 63,408 bottles
This recall covers 5 products
The agency filed one notice per product. You are reading one of them; the other 4 are below.
Where it was sold
- Nationwide
Why it was recalled
CGMP Deviations: impurity N-nitrosoirbesartan detected in API
This product could cause temporary or reversible health problems — stop using it.
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