Recall Enforment Report D-0088-2022

Multi event Drug Recall Enforcement Report Class II voluntary initiated by Lupin Pharmaceuticals Inc., originally initiated on 10-12-2021 for the product Irbesartan Tablets USP, 300 mg a) 30 count (NDC 68180-412-06) and b) 90 count NDC# 68180-412-09) bottles, Rx only The product was recalled due to cgmp deviations: impurity n-nitrosoirbesartan detected in api. The product was distributed nationwide and the recall is currently ongoing.

Recall Enforcement Reports

Recall Number Initiation Date Report Date Recall Classification Quantity Product Description Recall Reason Status
D-0088-202210-12-202111-10-2021Class II119,544 bottlesIrbesartan Tablets USP, 300 mg a) 30 count (NDC 68180-412-06) and b) 90 count NDC# 68180-412-09) bottles, Rx onlyCGMP Deviations: impurity N-nitrosoirbesartan detected in APIOngoing
D-0086-202210-12-202111-10-2021Class II51,144 bottlesIrbesartan Tablets USP, 75 mg a) 30 count (NDC 68180-410-06) and b) 90 count (NDC 68180-410-09) bottles, Rx onlyCGMP Deviations: impurity N-nitrosoirbesartan detected in APIOngoing
D-0089-202210-12-202111-10-2021Class II63,408 bottlesIrbesartan 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 onlyCGMP Deviations: impurity N-nitrosoirbesartan detected in APIOngoing
D-0090-202210-12-202111-10-2021Class II98,052 bottlesIrbesartan and Hydrochlorothiazide Tablets USP, 300/12.5 mg a) 30 count (NDC 68180-414-06) and b) 90 count (NDC 68180-414-09) bottles, Rx onlyCGMP Deviations: impurity N-nitrosoirbesartan detected in APIOngoing
D-0087-202210-12-202111-10-2021Class II134,016 bottlesIrbesartan Tablets USP, 150 mg a) 30 count (NDC 68180-411-06) and b) 90 count (NDC 68180-411-09) bottles, Rx onlyCGMP Deviations: impurity N-nitrosoirbesartan detected in APIOngoing

Recalled Products

NDC Proprietary Name Non-Proprietary Name Dosage Form Route Name Company Name Product Type
68180-410Irbesartan IrbesartanTabletOralLupin Pharmaceuticals, Inc.Human Prescription Drug
68180-411Irbesartan IrbesartanTabletOralLupin Pharmaceuticals, Inc.Human Prescription Drug
68180-412Irbesartan IrbesartanTabletOralLupin Pharmaceuticals, Inc.Human Prescription Drug
68180-413Irbesartan And Hydrochlorothiazide Irbesartan And HydrochlorothiazideTablet, Film CoatedOralLupin Pharmaceuticals, Inc.Human Prescription Drug
68180-414Irbesartan And Hydrochlorothiazide Irbesartan And HydrochlorothiazideTablet, Film CoatedOralLupin Pharmaceuticals, Inc.Human Prescription Drug