A Baltimore-based company is recalling some of its birth control pills, due to the risk of contraceptive failure, according to the FDA.
According to an FDA statement, Lupin Pharmaceuticals Inc. is recalling a specific lot of its Mibelas 24 Fe tablets. The lot affected has the lot number of L600518, with an expiry date of May 31, 2018. A market complaint, which has reportedly been confirmed, indicate that a packaging error has rotated the blister 180 degrees within the wallet, which reverses the weekly tablet orientation, and meant those on the first four days of therapy would have had the four non-hormonal placebo tablets, instead of the active tablets.
FDA officials said as a result, oral contraceptive tablets that are taken out of sequence could place the user at risk of contraceptive failure and unintended pregnancy. Lupin, according to the statement, is notifying its distributors and customers by recall letter, and is arranging for the return of all recalled products. Those who have the affected product should notify their physician, and return the product to the pharmacy, or to the place of purchase.
Those with questions can call Lupin Pharmaceuticals at 1-800-399-2561, from 8:00 a.m. to 5:00 p.m. (Eastern Time), Monday through Friday.