Irbesartan Tablets USP, 75 mg a) 30 count (NDC 68180-410-06) and b) 90 count (NDC 68180-410-09) bottles, Rx only
Summary
The FDA issued a Class II for Irbesartan Tablets USP, 75 mg a) 30 count (NDC 68180-410-06) and b) 90 count (N by Lupin Pharmaceuticals Inc.. Reason: CGMP Deviations: impurity N-nitrosoirbesartan detected in API.
Details
Source
Drug Recall
External ID
D-0086-2022
Action Date
2021-11-10
Status
Terminated
Category
drug
Product Description
Irbesartan Tablets USP, 75 mg a) 30 count (NDC 68180-410-06) and b) 90 count (NDC 68180-410-09) bottles, Rx only
Lot/Code Info: a) Lot# H000843, exp. date 28/02/2023 H805727, exp. date 30/11/2021 H901579, exp. date 31/03/2022 b) Lot# H000844, exp. date 28/02/2023 H000964, exp. date 31/03/2023 H804311, exp. date 31/08/2021 H805267, exp. date 30/11/2021 H805268, exp. date 30/11/2021 H805269, exp. date 30/11/2021 H805725, exp. date 30/11/2021 H805726, exp. date 30/11/2021 H901497, exp. date 31/01/2022 H901577, exp. date 31/03/2022 H901578, exp. date 31/03/2022 H902258, exp. date 31/05/2022
Quantity Affected: 51,144 bottles
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2021-10-12
Company
Baltimore, MD
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 79 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Lupin Pharmaceuticals Inc. has 49 FDA actions in our database, including 49 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Lupin Pharmaceuticals Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Lupin Pharmaceuticals Inc. have FDA actions?
Lupin Pharmaceuticals Inc. has 49 FDA actions in our database, including 49 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0086-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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