Lupin Pharmaceuticals recalls birth control pills

Photo source: FDA

The product tested low for ascorbic acid and high for a known impurity

Lupin Pharmaceuticals is recalling recalling two lots of Tydemy (Drospirenone, Ethinyl Estradiol and Levomefolate Calcium Tablets).

One lot of the birth control pills tested low for ascorbic acid (an inactive ingredient) and high for a known impurity.

There have been no reports of adverse events. However, if there were a significant reduction in the amount of ascorbic acid, this could potentially affect the effectiveness of the product which could potentially result in unexpected pregnancy.

A list of the lots of the product, packaged in 28’s blister and distributed nationwide to wholesalers, drug chains, mail order pharmacies and supermarkets, may be found here.

What to do

Patients taking Tydemy should continue taking their medication and immediately contact their pharmacist, physician, or medical provider for advice regarding an alternative treatment.

Consumers with questions may contact Inmar Rx Solutions, Inc. at (866) 480-8206 Monday – Friday 09:00 am to 05:00 pm (EST).

For reimbursement, consumers must have the recalled lots returned to Inmar Rx Solutions, Inc.; the lot number can be found on the side of the carton.

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