Recall: D-0086-2022

Class II - Potentially Harmful

Class IIClassification

2021-10-12Initiated

TerminatedStatus

Lupin Pharmaceuticals Inc.Firm

Product

Irbesartan Tablets USP, 75 mg a) 30 count (NDC 68180-410-06) and b) 90 count (NDC 68180-410-09) bottles, Rx only

Reason

CGMP Deviations: impurity N-nitrosoirbesartan detected in API

Distribution

Product was distributed to major distributors who may have further distributed the product nationwide.

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.