Lupin Pharmaceuticals, Inc. Issues Voluntarily Nationwide Recall of all Irbesartan Tablets and Irbesartan and Hydrochlorothiazide Tablets due to potential presence of N-nitrosoirbesartan Impurity

Published: Oct. 14, 2021 at 3:34 AM AKDT

BALTIMORE, Oct. 14, 2021 /PRNewswire/ -- Lupin Pharmaceuticals Inc. is voluntarily recalling the below-mentioned batches of Irbesartan Tablets and Irbesartan and Hydrochlorothiazide Tablets to the consumer level. As part of Lupin's ongoing assessment, analysis revealed that certain tested API batches (but not finished product batches) were above the specification limit for the impurity, N-nitrosoirbesartan. Although Lupin has received no reports of illness that appear to relate to this issue, the company, out of an abundance of caution, is recalling all batches of Irbesartan Tablets USP 75mg, 150mg and 300mg and Irbesartan and Hydrochlorothiazide Tablets USP, 150mg/12.5mg and 300mg/12.5mg in the US.

Product labels
Product labels

Lupin discontinued the marketing of Irbesartan and Irbesartan and HCTZ tabs in Jan 2021.

Risk Statement: N-nitrosoirbesartan impurity is a probable human carcinogen (a substance that could cause cancer) based on results from laboratory tests.

From October 8, 2018 (the earliest date of shipment from the manufacturing site of any of the affected batches), to September 30, 2021, Lupin received 4 reports of illness from Irbesartan and 0 reports from Irbesartan and Hydrochlorothiazide.

Irbesartan tablet USP is an angiotensin II receptor blocker indicated for treatment of hypertension, to lower blood pressure, diabetic nephropathy in hypertensive patients with type 2 diabetes, an elevated serum creatinine, and proteinuria. Irbesartan Tablets USP 75mg, 150mg and 300mg is packaged in 30 and 90 count bottles and was distributed nationwide in the US to wholesalers, drug chains, mail order pharmacies and supermarkets. Lupin discontinued the marketing of Irbesartan Tablets on Jan 7, 2021. The recalled lots are included in the table below:

Product

Lot No

 NDC

Distribution Dates

Irbesartan Tablets USP, 75mg

H000843, H805727, H901579

68180-410-06 (30's)

10/20/2018

 12/03/2020

H000844, H000964, H804311,

H805267, H805268, H805269,

H805725, H805726, H901497,

H901577, H901578, H902258

68180-410-09 (90's)

Irbesartan Tablets USP, 150mg

H804403, H805251, H805640,

H901580

68180-411-06 (30's)

H804492, H805252, H805253,

H805641, H805642, H805643,

H901581, H902139, H902140

68180-411-09 (90's)

Irbesartan Tablets USP, 300mg

H804310, H900050, H902262

68180-412-06 (30's)

H000845, H000846, H000965,

H805345, H805346, H805347,

H805724, H900061, H900062,

H900445, H901489, H901490,

H901491, H902261

68180-412-09 (90's)

Irbesartan and hydrochlorothiazide tablet USP is a combination of irbesartan, an angiotensin II receptor antagonist, and hydrochlorothiazide, a thiazide diuretic, indicated for hypertension in patients not adequately controlled with monotherapy or as an initial therapy in patients likely to need multiple drugs to achieve their blood pressure goals. Irbesartan and hydrochlorothiazide tablet USP, 150mg/12.5mg and 300mg/12.5mg is packaged in 30 and 90 count bottles and was distributed nationwide in the US to wholesalers, drug chains, mail order pharmacies and supermarkets. Lupin discontinued the marketing of Irbesartan and HCTZ Tablets on Jan 7, 2021. The recalled lots are included in the table below:

Product

Lot No

 NDC

Distribution Dates

Irbesartan and

Hydrochlorothiazide Tablets USP,

150mg/12.5mg

H804537, H805148,

H900063, H900522,

H901582

68180-413-06 (30's)

10/17/2018

 11/18/2020

H000963, H804507,

H804536, H805070,

H805149, H900064,

H900523, H901583,

H902530

68180-413-09 (90's)

Irbesartan and

Hydrochlorothiazide Tablets USP,

300mg/12.5mg

H804192, H805348,

H900065, H902264

68180-414-06 (30's)

H804082, H804121,

H804338, H804538,

H804539, H805349,

H805350, H900066,

H900067, H902265,

H902275, H902276,

H902531, H902532

68180-414-09 (90's)

Lupin Pharmaceuticals Inc. is notifying its wholesalers, distributors, drug chains, mail order pharmacies and supermarkets by phone and through recall notification and is arranging for the return of all the recalled product lots.

Patients taking, Irbesartan Tablets USP, 75mg, 150mg and 300mg and Irbesartan and Hydrochlorothiazide Tablets USP, 150mg/12.5mg and 300mg/12.5mg are advised to continue taking their medication and contact their pharmacist, physician, or medical provider for advice regarding an alternative treatment.

Wholesalers, distributors and retailers that have Irbesartan Tablets USP, 75mg, 150mg and 300mg and Irbesartan and Hydrochlorothiazide Tablets USP, 150mg/12.5mg and 300mg/12.5mg that are being recalled should discontinue distribution of the recalled product lots immediately and return it to Inmar Rx Solutions, Inc., 635 Vine St, Winston Salem, NC 27101. Tel: (855) 769-3988 / (855) 769-3989.

Consumers, wholesalers, distributors, and retailers with questions regarding this recall should contact Inmar Rx Solutions, Inc. at (855) 769-3988 / (855) 769-3989 Monday – Friday 09:00 am to 05:00 pm EST. For reimbursement, please have the recalled lots returned to Inmar Rx Solutions, Inc.; the lot number can be found on the side of the bottle label.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

About Lupin Pharmaceuticals

Lupin Pharmaceuticals, Inc. is the U.S. based wholly-owned subsidiary of Lupin Limited and is the 3rd largest pharmaceutical company in the U.S. based on total prescriptions. Together, all Lupin-owned entities combine to make up the 8th largest generic pharmaceutical company in the world by revenue size. Lupin Pharmaceuticals, Inc. is dedicated to delivering high-quality medications across many treatment areas. Lupin Pharmaceuticals Inc.'s branded pharmaceuticals division, is the provider of products designed to help prevent and manage women's health conditions with serious health consequences.

© 2020 Lupin Pharmaceuticals, Inc. All rights reserved.

Company Contact:
Shweta Munjal
Email: shwetamunjal@lupin.com

Product labels
Product labels
Product labels
Product labels
Lupin Pharmaceuticals Logo (PRNewsfoto/Lupin Pharmaceuticals, Inc.)
Lupin Pharmaceuticals Logo (PRNewsfoto/Lupin Pharmaceuticals, Inc.)

View original content to download multimedia:

SOURCE Lupin Pharmaceuticals, Inc.

The above press release was provided courtesy of PRNewswire. The views, opinions and statements in the press release are not endorsed by Gray Media Group nor do they necessarily state or reflect those of Gray Media Group, Inc.