Lupine Pharmaceuticals, Inc. Issuing Nationwide Voluntary Recall of All Irbesartan and Irbesartan and Hydrochlorothiazide Tablets Due to Potential Presence of N-Nitrosoirbesartan Impurities

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Summary

Company announcement date:
FDA Release Date:
Type of product:
Medications
Reason for listing:

Reason for recall Description

API lots above specification limit for impurity, N-nitrosoirbesartan

Company Name:
Lupine Pharmaceuticals, Inc.
Mark:
Product Description:

Product Description

Irbesartan and Hydrochlorothiazide Tablets USP, 150 mg / 12.5 mg and 300 mg / 12.5 mg


Company announcement

Baltimore, Maryland, October 14, 2021: Lupine Pharmaceuticals Inc. is voluntarily recalling the below mentioned lots of irbesartan tablets and irbesartan and hydrochlorothiazide tablets from consumers. As part of Lupine’s ongoing evaluation, analysis revealed that some tested lots of APIs (but not finished product lots) were above the specification limit for the impurity, N-nitrosoirbesartan . Although Lupine has not received any reports of illness that appear to be related to this issue, the company, out of caution, is recalling all lots of irbesartan tablets USP 75 mg, 150 mg and 300 mg and irbesartan tablets and d. hydrochlorothiazide USP, 150 mg / 12.5 mg and 300 mg / 12.5 mg in the United States.

Lupine discontinued the marketing of Irbesartan and Irbesartan and HCTZ tablets in January 2021.

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

From October 8, 2018 (the first date of shipment from the manufacturing site of one of the affected lots) through September 30, 2021, Lupine received 4 reports of Irbesartan disease and 0 reports of Irbesartan and Hydrochlorothiazide.

Irbesartan Tablets 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, elevated serum creatinine and proteinuria. Irbesartan Tablets USP 75 mg, 150 mg and 300 mg are supplied in bottles of 30 and 90 and have been distributed nationwide in the United States to wholesalers, drugstores, mail order pharmacies and supermarkets. . Lupine discontinued the marketing of irbesartan tablets on January 7, 2021. The recalled batches are included in the table below:

Product

Lot

NDC

Release dates

Irbesartan Tablets USP, 75 mg

H000843, H805727, H901579

68180-410-06 (1930s

20/10/2018

03/12/2020

H000844, H000964, H804311,
H805267, H805268, H805269,
H805725, H805726, H901497,
H901577, H901578, H902258

68180-410-09 (1990s

Irbesartan Tablets USP, 150 mg

H804403, H805251, H805640,
H901580

68180-411-06 (30 years old

H804492, H805252, H805253,
H805641, H805642, H805643,
H901581, H902139, H902140

68180-411-09 (1990s

Irbesartan Tablets USP, 300 mg

H804310, H900050, H902262

68180-412-06 (1930s

H000845, H000846, H000965,
H805345, H805346, H805347,
H805724, H900061, H900062,
H900445, H901489, H901490,
H901491, H902261

68180-412-09 (1990s

Irbesartan and hydrochlorothiazide tablet USP are a combination of irbesartan, an angiotensin II receptor antagonist, and hydrochlorothiazide, a thiazide diuretic, indicated for hypertension in patients insufficiently controlled by monotherapy. or as an initial treatment in patients who may need more than one medicine to obtain their blood. pressure targets. Irbesartan and Hydrochlorothiazide Tablets USP, 150 mg / 12.5 mg and 300 mg / 12.5 mg are packaged in bottles of 30 and 90 units and have been distributed in the United States to wholesalers, pharmaceutical chains , mail order pharmacies and supermarkets. Lupine discontinued the marketing of irbesartan and HCTZ tablets on January 7, 2021. The recalled batches are included in the table below:

Product

Lot

NDC

Release dates

Irbesartan and
Hydrochlorothiazide Tablets USP,
150 mg / 12.5 mg

H804537, H805148,
H900063, H900522,
H901582

68180-413-06 (1930s

10/17/2018

11/18/2020

H000963, H804507,
H804536, H805070,
H805149, H900064,
H900523, H901583,
H902530

68180-413-09 (1990s

Irbesartan and
Hydrochlorothiazide Tablets USP,
300 mg / 12.5 mg

H804192, H805348,
H900065, H902264

68180-414-06 (1930s

H804082, H804121,
H804338, H804538,
H804539, H805349,
H805350, H900066,
H900067, H902265,
H902275, H902276,
H902531, H902532

68180-414-09 (1990s

Lupine Pharmaceuticals Inc. notifies its wholesalers, distributors, drugstore chains, mail order pharmacies and supermarkets by telephone and by recall notice and arranges for the return of all batches of recalled products.

Patients taking irbesartan tablets USP, 75 mg, 150 mg and 300 mg and irbesartan and hydrochlorothiazide tablets USP, 150 mg / 12.5 mg and 300 mg / 12.5 mg, are advised to continue to take their medicine and to contact their pharmacist, doctor or healthcare professional for advice on an alternative treatment.

Wholesalers, distributors and retailers who have irbesartan tablets USP, 75 mg, 150 mg and 300 mg and irbesartan and hydrochlorothiazide tablets USP, 150 mg / 12.5 mg and 300 mg / 12.5 mg that are the subject of a recall must immediately cease distribution of the batches of recalled products and return them 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 through Friday 9:00 am to 5:00 pm EST. For reimbursement, please return the recalled lots to Inmar Rx Solutions, Inc .; the lot number can be found on the side of the bottle label.

Adverse reactions or quality issues encountered while using this product can be reported to the FDA’s MedWatch Adverse Event Reporting Program, online, by mail, or by fax.

  • Complete and submit the report online
  • Regular Mail or Fax: Download the form or call 1-800-332-1088 to request a report form, then complete and return it to the address on the pre-addressed form, or fax it to 1-800-FDA-0178

This recall is being made with the knowledge of the United States Food and Drug Administration.


Company details

Consumers:
Inmar Rx Solutions, Inc.
(855) 769-3988 / (855) 769-3989


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