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Lupin announced a voluntary recall of one lot of Mibelas 24 Fe (norethindrone acetate and ethinyl estradiol chewable and ferrous fumarate) tablets after a complaint of a packaging error.
Mibelas 24 Fe is an oral contraceptive indicated to prevent pregnancy in women who choose to use oral contraceptives. It is supplied as blister packs containing 24 active tablets and 4 inert tablets. The recalled product has Lot #L600518 with an expiration date of 5/31/2018 and is packaged as a wallet of 28 tablets or a carton of 3 wallets.
The report showed that the blister was turned 180 degrees within the wallet, reversing the weekly tablet arrangement. This would provide the first 4 days of therapy with 4 non-hormonal placebo tablets vs. the active tablets. The lot number and expiration date were also no longer visible as result of the rotated blister.
Oral contraceptive tablets that are taken in the wrong order may place the user at risk for contraceptive failure and unintended pregnancy. The reversed order may not be obvious to first-time users or previous users, which may further increase the risk of taking the pills out of sequence. If pregnancy is contraindicated for some patients or if concomitant medication(s) carry teratogenic effects, an unintended pregnancy can lead to significant health consequences for the mother or fetus.
To date, Lupin has not received any reports of such adverse events. The Company is notifying its distributors and customers via a recalled letter and is arranging for return of all recalled products.
For more information call (800) 399-2561 or visit FDA.gov.
