D-0089-2022 Class II Terminated
FDA drug recall D-0089-2022 was initiated by Lupin Pharmaceuticals Inc. on October 12, 2021 and is designated Class II. Reason for recall: CGMP Deviations: impurity N-nitrosoirbesartan detected in API The recall status is terminated (terminated January 30, 2023). Affected quantity: 63,408 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- November 10, 2021
- Initiation Date
- October 12, 2021
- Termination Date
- January 30, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 63,408 bottles
Product Description
Irbesartan 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 only
Reason for Recall
CGMP Deviations: impurity N-nitrosoirbesartan detected in API
Distribution Pattern
Product was distributed to major distributors who may have further distributed the product nationwide.
Code Information
a) Lot# H804537, exp. date 30/09/2021 H805148, exp. date 31/10/2021 H900063, exp. date 31/10/2021 H900522, exp. date 31/12/2021 H901582, exp. date 31/01/2022 b) Lot# H000963, exp. date 30/04/2022 H804507, exp. date 30/04/2022 H804536, exp. date 30/09/2021 H805070, exp. date 31/10/2021 H805149, exp. date 31/10/2021 H900064, exp. date 31/12/2021 H900523, exp. date 31/01/2022 H901583, exp. date 30/04/2022 H902530, exp. date 30/04/2022