FDA-Drug2021-11-10Class II
Irbesartan Tablets USP, 300 mg a) 30 count (NDC 68180-412-06) and b) 90 count NDC# 68180-412-09) 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
119,544 bottles
Manufactured in
Harborplace Tower, 111 S Calvert St Fl 21st, Baltimore, MD, United States
Products
Irbesartan Tablets USP, 300 mg a) 30 count (NDC 68180-412-06) and b) 90 count NDC# 68180-412-09) bottles, Rx only
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0088-2022Don't want to check this manually?
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