Lupin Pharmaceuticals Inc. recalls Irbesartan and Hydrochlorothiazide Tablets USP, 300/12.5 mg a) 30 count (NDC 68180-414-06) and b) 90 count (NDC 68180-4
Recalled November 10, 2021 · FDA recall D-0090-2022 · Lupin Pharmaceuticals
Hazard
CGMP Deviations: impurity N-nitrosoirbesartan detected in API · FDA Class II
Units
98,052 bottles
Sold at
Product was distributed to major distributors who may have further distributed the product nationwide.
Description
CGMP Deviations: impurity N-nitrosoirbesartan detected in API
Product
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
Manufacturer(s)
Lupin Pharmaceuticals Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →