FDA Drug Moderate Class II Terminated

Irbesartan 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 only

Reported: November 10, 2021 Initiated: October 12, 2021 #D-0090-2022

Product Description

Reason for Recall

CGMP Deviations: impurity N-nitrosoirbesartan detected in API

Details

Recalling Firm: Lupin Pharmaceuticals Inc.
Units Affected: 98,052 bottles
Distribution: Product was distributed to major distributors who may have further distributed the product nationwide.
Location: Baltimore, MD

Frequently Asked Questions

What product was recalled? ▼

Irbesartan 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 only. Recalled by Lupin Pharmaceuticals Inc.. Units affected: 98,052 bottles.

Why was this product recalled? ▼

CGMP Deviations: impurity N-nitrosoirbesartan detected in API

Which agency issued this recall? ▼

This recall was issued by the FDA Drug on November 10, 2021. Severity: Moderate. Recall number: D-0090-2022.