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ALERT: Recall Of 2 Hypertension Medications

1 month, 3 weeks ago

3912  0
Posted on Oct 15, 2021, 1 p.m.

According to a Safety Summary Alert, the FDA has announced that Lupin Pharmaceuticals is recalling multiple lots of two different medications, irbesartan tablets and irbesartan and hydrochlorothiazide tablets, used to treat hypertension. The reason for the recall is the potential presence of unacceptable levels of N-nitrosoirbesartan, a contaminant associated with cancer. At this time, there have been no reports of illness related to this issue.

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, the 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.

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 the 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 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 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.



As with anything you read on the internet, this article should not be construed as medical advice; please talk to your doctor or primary care provider before making any changes to your wellness routine.

Content may be edited for style and length.

Materials provided by:

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/lupin-pharmaceuticals-inc-issues-voluntarily-nationwide-recall-all-irbesartan-tablets-and-irbesartan?utm_medium=email&utm_source=govdelivery

shwetamunjal@lupin.com

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