Irbesartan Tablets USP, 300 mg a) 30 count (NDC 68180-412-06) and b) 90 count NDC# 68180-412-09) bottles, Rx only
Check against the official notice below — it lists the full affected range.
Lupin Pharmaceuticals Inc. is recalling Irbesartan Tablets USP 300 mg in both 30-count and 90-count bottles due to current Good Manufacturing Practice (CGMP) deviations. The recall was initiated because the active pharmaceutical ingredient was found to contain the impurity N-nitrosoirbesartan. A total of 119,544 bottles were distributed to major distributors who may have further distributed the product nationwide.
The affected products include multiple lots with various expiration dates ranging from August 2021 through March 2023. Consumers should check their medication bottles against the specific lot numbers and expiration dates listed in the recall notice to determine if their product is affected. The source document does not specify a remedy or instructions for what affected consumers should do with their medication.
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: 119,544 bottles Lot/code info: a) Lot# H804310, exp. date 31/08/2021 H900050, exp. date 30/11/2021 H902262, exp. date 31/05/2022 b) Lot# H000845, exp. date 28/02/2023 H000846, exp. date 28/02/2023 H000965, exp. date 31/03/2023 H805345, exp. date 30/11/2021 H805346, exp. date 30/11/2021 H805347, exp. date 30/11/2021 H805724, exp. date 30/11/2021 H900061, exp. date 31/12/2021 H900062, exp. date 31/12/2021 H900445, exp. date 31/01/2022 H901489, exp. date 31/03/2022 H901490, exp. date 31/03/2022 H901491, exp. date 31/03/2022 H902261, exp. date 31/05/2022
Official record: FDA (Drug enforcement) ↗
Republished from the official source above; details can change — the source record controls.