Abstract

Corporate Announcement Date:
FDA Put up Date:
Product Kind:
Medicine

Reason why for Announcement:

Recall Reason why Description

API batches above the specification prohibit for the impurity, N-nitrosoirbesartan

Corporate Identify:
Lupin Prescription drugs, Inc.
Emblem Identify:
Product Description:

Product Description

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


Corporate Announcement

Baltimore, Maryland, October 14, 2021: Lupin Prescription drugs Inc. is voluntarily recalling the below-mentioned batches of Irbesartan Drugs and Irbesartan and Hydrochlorothiazide Drugs to the shopper stage. As a part of Lupin’s ongoing evaluation, research printed that positive examined API batches (however now not completed product batches) have been above the specification prohibit for the impurity, N-nitrosoirbesartan. Despite the fact that Lupin has gained no studies of sickness that seem to narrate to this factor, the corporate, out of an abundance of warning, is recalling all batches of Irbesartan Drugs USP 75mg, 150mg and 300mg and Irbesartan and Hydrochlorothiazide Drugs USP, 150mg/12.5mg and 300mg/12.5mg in the United States.

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

Chance Observation: N-nitrosoirbesartan impurity is a likely human carcinogen (a substance that would purpose most cancers) in accordance with effects from laboratory checks.

From October 8, 2018 (the earliest date of cargo from the producing website of any of the affected batches), to September 30, 2021, Lupin gained 4 studies of sickness from Irbesartan and nil studies from Irbesartan and Hydrochlorothiazide.

Irbesartan pill USP is an angiotensin II receptor blocker indicated for remedy of high blood pressure, to decrease blood power, diabetic nephropathy in hypertensive sufferers with sort 2 diabetes, an increased serum creatinine, and proteinuria. Irbesartan Drugs USP 75mg, 150mg and 300mg is packaged in 30 and 90 rely bottles and was once dispensed national in the United States to wholesalers, drug chains, mail order pharmacies and supermarkets. Lupin discontinued the promoting of Irbesartan Drugs on Jan 7, 2021. The recalled loads are incorporated within the desk beneath:

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Product

Lot No

NDC

Distribution Dates

Irbesartan Drugs 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 Drugs 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 Drugs 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 pill USP is a mix of irbesartan, an angiotensin II receptor antagonist, and hydrochlorothiazide, a thiazide diuretic, indicated for high blood pressure in sufferers now not adequately managed with monotherapy or as an preliminary remedy in sufferers more likely to want a couple of medicine to succeed in their blood power objectives. Irbesartan and hydrochlorothiazide pill USP, 150mg/12.5mg and 300mg/12.5mg is packaged in 30 and 90 rely bottles and was once dispensed national in the United States to wholesalers, drug chains, mail order pharmacies and supermarkets. Lupin discontinued the promoting of Irbesartan and HCTZ Drugs on Jan 7, 2021. The recalled loads are incorporated within the desk beneath:

Product

Lot No

NDC

Distribution Dates

Irbesartan and
Hydrochlorothiazide Drugs 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 Drugs 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
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Lupin Prescription drugs Inc. is notifying its wholesalers, vendors, drug chains, mail order pharmacies and supermarkets via telephone and thru recall notification and is arranging for the go back of all of the recalled product loads.

Sufferers taking, Irbesartan Drugs USP, 75mg, 150mg and 300mg and Irbesartan and Hydrochlorothiazide Drugs USP, 150mg/12.5mg and 300mg/12.5mg are recommended to proceed taking their drugs and phone their pharmacist, doctor, or clinical supplier for recommendation referring to an alternate remedy.

Wholesalers, vendors and outlets that experience Irbesartan Drugs USP, 75mg, 150mg and 300mg and Irbesartan and Hydrochlorothiazide Drugs USP, 150mg/12.5mg and 300mg/12.5mg which can be being recalled will have to discontinue distribution of the recalled product loads right away and go back it to Inmar Rx Answers, Inc., 635 Vine St, Winston Salem, NC 27101. Tel: (855) 769-3988 / (855) 769-3989.

Shoppers, wholesalers, vendors, and outlets with questions referring to this recall will have to touch Inmar Rx Answers, Inc. at (855) 769-3988 / (855) 769-3989 Monday – Friday 09:00 am to 05:00 pm EST. For repayment, please have the recalled loads returned to Inmar Rx Answers, Inc.; the lot quantity may also be discovered at the aspect of the bottle label.

Hostile reactions or high quality issues skilled with the usage of this product is also reported to the FDA’s MedWatch Hostile Tournament Reporting program both on-line, via common mail or via fax.

  • Whole and put up the file On-line
  • Common Mail or Fax: Obtain shape or name 1- 800-332-1088 to request a reporting shape, then whole and go back to the cope with at the pre-addressed shape, or put up via fax to 1-800-FDA-0178
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This recall is being carried out with the information of the U.S. Meals and Drug Management.


Corporate Touch Data

Shoppers:
Inmar Rx Answers, Inc.