FDA-Drug2021-11-10Class II
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
Lupin Pharmaceuticals Inc.
Hazard
CGMP Deviations: impurity N-nitrosoirbesartan detected in API
Sold states
Product was distributed to major distributors who may have further distributed the product nationwide.
Affected count
63,408 bottles
Manufactured in
Harborplace Tower, 111 S Calvert St Fl 21st, Baltimore, MD, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0089-2022Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief