Irbesartan Tablets USP, 75 mg a) 30 count (NDC 68180-410-06) and b) 90 count (NDC 68180-410-09) bottles, Rx only
Check against the official notice below — it lists the full affected range.
Lupin Pharmaceuticals Inc. is recalling Irbesartan Tablets USP 75 mg in both 30-count and 90-count bottles due to the detection of the impurity N-nitrosoirbesartan in the active pharmaceutical ingredient. This represents a manufacturing deviation from good manufacturing practices (CGMP). A total of 51,144 bottles were distributed to major distributors who may have further distributed the product nationwide, with multiple affected lot numbers and expiration dates ranging from August 2021 through February 2023.
The recall record does not specify a remedy or recommended action for affected consumers.
Written by software from the official notice below. Not reviewed by a lawyer.
CGMP Deviations: impurity N-nitrosoirbesartan detected in API
Reason for recall: CGMP Deviations: impurity N-nitrosoirbesartan detected in API Distribution: Product was distributed to major distributors who may have further distributed the product nationwide. Quantity: 51,144 bottles Lot/code info: a) Lot# H000843, exp. date 28/02/2023 H805727, exp. date 30/11/2021 H901579, exp. date 31/03/2022 b) Lot# H000844, exp. date 28/02/2023 H000964, exp. date 31/03/2023 H804311, exp. date 31/08/2021 H805267, exp. date 30/11/2021 H805268, exp. date 30/11/2021 H805269, exp. date 30/11/2021 H805725, exp. date 30/11/2021 H805726, exp. date 30/11/2021 H901497, exp. date 31/01/2022 H901577, exp. date 31/03/2022 H901578, exp. date 31/03/2022 H902258, exp. date 31/05/2022
Official record: FDA (Drug enforcement) ↗
Republished from the official source above; details can change — the source record controls.