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  4. Vivimed Life Sciences Pvt Ltd Issues Voluntary Nationwide Recall of Losartan Potassium 25 mg, 50 mg and 100 mg Tablets, USP Due to the Detection of Trace Amounts of N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) Impurity
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COMPANY ANNOUNCEMENT

Vivimed Life Sciences Pvt Ltd Issues Voluntary Nationwide Recall of Losartan Potassium 25 mg, 50 mg and 100 mg Tablets, USP Due to the Detection of Trace Amounts of N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) Impurity

When a company announces a recall, market withdrawal, or safety alert, the FDA posts the company's announcement as a public service. FDA does not endorse either the product or the company.

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Vivimed Life Sciences Pvt Ltd Issues Voluntary Nationwide Recall of Losartan Potassium 25 mg, 50 mg and 100 mg Tablets, USP Due to the Detection of Trace Amounts of N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) Impurity

Summary

Company Announcement Date:
May 03, 2019
FDA Publish Date:
May 09, 2019
Product Type:
Drugs
Reason for Announcement:
Company Name:
Vivimed
Brand Name:
Brand Name(s)
Heritage
Product Description:
Product Description
Losartan Potassium Tablets USP

Company Announcement

Vivimed Life Sciences Pvt Ltd (Vivimed) is recalling 19 lots of Losartan Potassium Tablets USP 25 mg, 50 mg, and 100 mg to consumer level due to the detection of an N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) a possible process impurity or contaminant in an active pharmaceutical ingredient, manufactured by Hetero Labs Limited, (API manufacturer) that is above the US Food & Drug Administration’s interim acceptable exposure limit of 9.82 ppm. Based on the available information, the risk of developing cancer in a few patients following long-term use of the product containing high levels of the impurity NMBA cannot be ruled out.

This product is made by Vivimed at its Plant in Alathur, Chennai, India and Distributed by Heritage Pharmaceuticals Inc, East Brunswick NJ (Heritage). To date, neither Vivimed nor Heritage  has received any reports of adverse events related to this recall.

Losartan Potassium is indicated for the treatment of hypertension, hypertensive patients with left ventricular hypertrophy, nephropathy in Type 2 diabetic patients and is packaged in 90-count and 1000-count bottles. The lots were manufactured by Vivimed at its Plant in Alathur, Chennai, India and Distributed by Heritage Pharmaceuticals Inc, East Brunswick NJ (Heritage) .

The identifying NDC #s associated with Heritage distributed product are as follows:
Losartan Tablets 25 mg: 90- count: NDC 23155-644-09, Losartan Tablets 50 mg: 90- count: NDC 23155-645-09; 1000-count: NDC 23155-645-10, Losartan Tablets 100 mg: 90-count- NDC 23155-646-09   1000-count: NDC 23155-646-10.

The affected Losartan Potassium tablets, includes the 19 lot numbers which are listed below:

Product Name Lot Number Pack Expiry Date Distributed by 
Losartan Potassium Tablets USP, 25 mg CLO17006A 90’s Nov 2019 HERITAGE  
Losartan Potassium Tablets USP, 50 mg CLO17007A 1000's Nov 2019 HERITAGE   
Losartan Potassium Tablets USP, 50 mg CLO17008A 1000's Nov 2019 HERITAGE   
Losartan Potassium Tablets USP, 50 mg CLO17009A 1000's Nov 2019 HERITAGE   
Losartan Potassium Tablets USP, 50 mg CLO17009B 90's Nov 2019 HERITAGE   
Losartan Potassium Tablets USP, 50 mg CLO17010A 90's Nov 2019 HERITAGE   
Losartan Potassium Tablets USP, 100 mg CLO17012A 90's Nov 2019 HERITAGE   
Losartan Potassium Tablets USP, 100 mg CLO17013A 90's Nov 2019 HERITAGE   
Losartan Potassium Tablets USP, 100 mg CLO17014A 1000's Dec 2019 HERITAGE   
Losartan Potassium Tablets USP, 100 mg CLO17015A 1000's Jan 2020 HERITAGE   
Losartan Potassium Tablets USP, 100 mg CLO17016A 1000's Jan 2020 HERITAGE   
Losartan Potassium Tablets USP, 100 mg CLO17017A 1000's Jan 2020 HERITAGE   
Losartan Potassium Tablets USP, 100 mg CLO18001A 1000's Jan 2020 HERITAGE   
Losartan Potassium Tablets USP, 100 mg CLO18002A 90's Jan 2020 HERITAGE   
Losartan Potassium Tablets USP, 100 mg CLO18002B 1000's Jan 2020 HERITAGE   
Losartan Potassium Tablets USP, 100 mg CLO18020A 90's Apr 2020 HERITAGE   
Losartan Potassium Tablets USP, 100 mg CLO18021A 90's Apr 2020 HERITAGE   
Losartan Potassium Tablets USP, 100 mg CLO18022A 90's Apr 2020 HERITAGE  
Losartan Potassium Tablets USP, 50 mg CLO18023A 90's Apr 2020 HERITAGE  

Losartan Potassium Tablets were distributed Nationwide to Wholesalers, Distributors, Retail Pharmacies, and Mail Order Pharmacies.

Inmar is notifying distributors and other customers by recall notification and arranging for return of recalled product of Losartan Potassium Tablets from the above lots.

Consumers should contact their doctor for further guidance and potential change of treatment before they stop taking the product. Pharmacies and healthcare facilities that have the product being recalled from above listed lots should stop using and dispensing the product immediately. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.

Consumers with questions regarding this recall can contact Vivimed C/o Inmar at  1-877-861-3811 Monday – Friday, 9am – 5pm EST.

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

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


Company Contact Information

Consumers:
Vivimed Life Sciences Pvt Ltd
1-877-861-3811
rxrecalls@inmar.com
Media:
Mr. Jack Patterson
1-877-861-3811
rxrecalls@inmar.com

Product Photos