Irbesartan Tablets USP, 150 mg a) 30 count (NDC 68180-411-06) and b) 90 count (NDC 68180-411-09) bottles, Rx only
Check against the official notice below — it lists the full affected range.
Lupin Pharmaceuticals Inc. is recalling Irbesartan Tablets USP, 150 mg in both 30-count and 90-count bottles due to the detection of the impurity N-nitrosoirbesartan in the active pharmaceutical ingredient. This impurity resulted from current Good Manufacturing Practice (CGMP) deviations. A total of 134,016 bottles were distributed to major distributors who may have further distributed the product nationwide. The affected product includes multiple lot numbers with expiration dates ranging from August 2021 through April 2022.
The specific lot numbers affected are: for the 30-count bottles, lots H804403, H805251, H805640, and H901580; and for the 90-count bottles, lots H804492, H805252, H805253, H805641, H805642, H805643, H901581, H902139, and H902140. The recall source does not specify what remedy consumers should pursue.
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: 134,016 bottles Lot/code info: a) Lot# H804403, exp. date 31/08/2021 H805251, exp. date 30/11/2021 H805640, exp. date 30/11/2021 H901580; exp. date 30/04/2022 b) Lot# H804492, exp. date 31/08/2021 H805252, exp. date 30/11/2021 H805253, exp. date30/11/2021 H805641, exp. date30/11/2021 H805642, exp. date30/11/2021 H805643, exp. date 30/11/2021 H901581, exp. date 30/04/2021 H902139, exp. date 30/04/2022 H902140, exp. date 30/04/2022
Official record: FDA (Drug enforcement) ↗
Republished from the official source above; details can change — the source record controls.