Lupin Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of 2 Lots of TydemyTM (Drospirenone, Ethinyl Estradiol and Levomefolate Calcium Tablets 3mg/0.03mg/0.451mg and Levomefolate Calcium Tablets 0.451mg) due to out of specification (OOS) results at the 12-month stability time point

Lupin Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of 2 Lots of TydemyTM (Drospirenone, Ethinyl Estradiol and Levomefolate Calcium Tablets 3mg/0.03mg/0.451mg and Levomefolate Calcium Tablets 0.451mg) due to out of specification (OOS) results at the 12-month stability time point

BALTIMORE, Md, July 29, 2023 /PRNewswire/ –Lupin Pharmaceuticals Inc. (Lupin) is voluntarily recalling two (2) lots of Tydemy (Drospirenone, Ethinyl Estradiol and Levomefolate Calcium Tablets 3mg/0.03mg/0.451 mg and Levomefolate Calcium Tablets 0.451 mg) to the patient (consumer/user) level due to out of specification (OOS) test results at the 12-month stability time point.  Specifically, one lot (L200183) tested low for ascorbic acid (an inactive ingredient) and high for a known impurity.

To date, Lupin has received no reports of adverse events related to either recalled lots.  Regardless, Lupin is recalling two lots because if there were a significant reduction in the amount of inactive content (ascorbic acid), this could potentially impact the effectiveness of the product which could potentially result in unexpected pregnancy.

Tydemy is estrogen/progestin oral contraceptive (COC) indicated for use by women to prevent pregnancy and to raise folate levels in women who choose to use an oral contraceptive for contraception. Tydemy is packaged in 28’s blister. One such blister was then packed in a pouch along with one printed sleeve, one pack insert (with day label) and one oxygen absorber (Stabilox) sachet. The three pouches were packed in one carton.

The lots were distributed nationwide in the US to wholesalers, drug chains, mail order pharmacies and supermarkets. The recalled lots are included in the table below:

Product

Lot No

Expiry

NDC(s)

UPC

Distribution Dates

TydemyTM

L200183

Jan. 2024

 

68180-904-71

(1 Blister of 28 tablets each)

 

68180-904-73

(3 Blister of 28 tablets each)

368180904731

 

June 2022 to May 2023

L201560

Sep. 2024

Lupin 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, Tydemy are advised to continue taking their medication and immediately contact their pharmacist, physician, or medical provider for advice regarding an alternative treatment.

Wholesalers, distributors and retailers that have Tydemy that is being recalled should discontinue distribution of the recalled product lots immediately.

Consumers, wholesalers, distributors, and retailers with questions regarding this recall should contact Inmar Rx Solutions, Inc. at (866) 480-8206 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 carton. 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.

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.

Product Label:

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.

Photo – https://mma.prnewswire.com/media/2165328/Lupin_Pharmaceuticals_Inc.jpg

SOURCE Lupin Pharmaceuticals, Inc.

Originally published at https://www.prnewswire.com/news-releases/lupin-pharmaceuticals-inc-issues-voluntary-nationwide-recall-of-2-lots-of-tydemytm-drospirenone-ethinyl-estradiol-and-levomefolate-calcium-tablets-3mg0-03mg0-451mg-and-levomefolate-calcium-tablets-0-451mg-due-to-out-of-spec-301888778.html
Images courtesy of https://pixabay.com

Related Stories

best marketing company in Miami

Discover

Riko’s Pizza Announces Two New Full Restaurant and Bar...

Company to open its first location in Westport on 60 Charles Street in partnership...

Embrace Home Loans’ Patrick Holland Surpasses $1 Billion in...

Virginia-based loan officer hits major milestone in just 14 years at Embrace MIDDLETOWN, R.I.,...

MO’ Trullo’s Luxury Experience redefines well-being getaways in Italy’s...

6 hectares host two stunning properties for families and groups seeking secluded well-beingCISTERNINO and...

Wynn Las Vegas to Debut Fiola Mare, A Renowned...

The New Coastal Concept Will Overlook the Resort's Lake of Dreams  LAS VEGAS, July...

Spice Up Your Summer: African Dream Foods’ African Ghost...

ORANGE COUNTY, Calif., June 18, 2024 /PRNewswire/ -- Get ready to add some serious...

World Travel Holdings Ranked In Top 20 Of Travel...

Annual survey includes the largest, most successful retailers in the industryWAKEFIELD, Mass. , June 27,...
watch free celebrity tv