Lupin Pharmaceuticals Recalls 2 Lots of Tydemy and Levomefolate Calcium Tablets


Medical Recalls

quinapril and hydrochlorothiazide tablets
Pfizer Accuretic
dr. berne’s msm mist solution

Tydemy Box


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 batches. Regardless, Lupin is recalling these two batches 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.

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.

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.

Source: FDA

You Are Leaving Us

This link is being provided as a convenience and for informational purposes only it is not an endorsement or an approval of any of the products, services or opinions of the corporation or organization or individual.

Recallinsider.com bears no responsibility for the accuracy, legality or content of the external site or for that of subsequent links.

Consumer Contact: -

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. 

You Are Leaving Us

This link is being provided as a convenience and for informational purposes only it is not an endorsement or an approval of any of the products, services or opinions of the corporation or organization or individual.

Recallinsider.com bears no responsibility for the accuracy, legality or content of the external site or for that of subsequent links.

You Are Leaving Us

This link is being provided as a convenience and for informational purposes only it is not an endorsement or an approval of any of the products, services or opinions of the corporation or organization or individual.

Recallinsider.com bears no responsibility for the accuracy, legality or content of the external site or for that of subsequent links.

You Are Leaving Us

This link is being provided as a convenience and for informational purposes only it is not an endorsement or an approval of any of the products, services or opinions of the corporation or organization or individual.

Recallinsider.com bears no responsibility for the accuracy, legality or content of the external site or for that of subsequent links.

Product
Lot No
Expiry
NDC(s)
UPC
Distribution Dates

TydemyTM

L200183

L201560

Jan. 2024

Sep. 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


Report a Problem With This 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.

You Are Leaving Us

This link is being provided as a convenience and for informational purposes only it is not an endorsement or an approval of any of the products, services or opinions of the corporation or organization or individual.

Recallinsider.com bears no responsibility for the accuracy, legality or content of the external site or for that of subsequent links.

You Are Leaving Us

This link is being provided as a convenience and for informational purposes only it is not an endorsement or an approval of any of the products, services or opinions of the corporation or organization or individual.

Recallinsider.com bears no responsibility for the accuracy, legality or content of the external site or for that of subsequent links.

You Are Leaving Us

This link is being provided as a convenience and for informational purposes only it is not an endorsement or an approval of any of the products, services or opinions of the corporation or organization or individual.

Recallinsider.com bears no responsibility for the accuracy, legality or content of the external site or for that of subsequent links.

You Are Leaving Us

This link is being provided as a convenience and for informational purposes only it is not an endorsement or an approval of any of the products, services or opinions of the corporation or organization or individual.

Recallinsider.com bears no responsibility for the accuracy, legality or content of the external site or for that of subsequent links.

You Are Leaving Us

This link is being provided as a convenience and for informational purposes only it is not an endorsement or an approval of any of the products, services or opinions of the corporation or organization or individual.

Recallinsider.com bears no responsibility for the accuracy, legality or content of the external site or for that of subsequent links.

Related Posts

volara system
Baxter Issues Urgent Medical Device Recall for Volar System Single-Patient Use Circuit
Baxter Issues Urgent Medical Device Recall for Volar System Single-Patient Use Circuit
umary acido hialuronica
SoloVital Recalls Umary Acido Hialuronica, Suplemento Alimenticio 850 mg Capsules
SoloVital Recalls Umary Acido Hialuronica, Suplemento Alimenticio 850 mg Capsules
hard steel logo
Supercore Products Group, Inc. Recalls Hard Steel Capsules and Gold Hard Steel Plus Liquid
Supercore Products Group, Inc. Recalls Hard Steel Capsules and Gold Hard Steel Plus Liquid
life 2000 ventilator
Baxter Recalls Life2000 Ventilator due to Charger Issues
Baxter Recalls Life2000 Ventilator due to Charger Issues

Latest Posts

bissell steam shot handheld steam cleaner
BISSELL Recalls More Than 3 Million Steam Shot Handheld Steam Cleaners Due to Burn Hazard
manhattan toy brilliant bee rattle
Sassy Baby Recalls Manhattan Toy Brilliant Bee Rattles Due to Choking Hazard
cfmoto zforce 950 ho sport side by side rov
CFMOTO Recalls ZFORCE 950 Recreational Off-Highway Vehicles
clonazepam orally disintegrating tablets
Endo USA, Inc. Recalls Lot 550147301 of Clonazepam Orally Disintegrating Tablets
one of the recalled hotdog products
AW Farms Recalls Ready-To-Eat Hot Dog Products

Leave a Reply

Your email address will not be published. Required fields are marked *

You Are Leaving Us

This link is being provided as a convenience and for informational purposes only it is not an endorsement or an approval of any of the products, services or opinions of the corporation or organization or individual.

Recallinsider.com bears no responsibility for the accuracy, legality or content of the external site or for that of subsequent links.