Lupin Recalls Mibelas 24 Fe

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The company recalled the tablets due to a packaging error.

On May 25, 2017, Lupin Pharmaceuticals Inc. announced it was voluntarily recalling lot L600518, Exp 05/18 of its contraceptive, Mibelas 24 Fe (Norethindrone Acetate and Ethinyl Estradiol 1 mg/0.02 mg chewable and ferrous fumarate 75 mg) tablets. The recall was enacted after the company received a complaint of a blister pack rotated 180 degrees in the wallet, which reversed the weekly tablet orientation and reduced the visibility of the lot number and expiration date.

The packaging error is significant because the first four days would have had placebo tablets instead of active tablets. The company stated that users may not notice the reverse order, which could cause contraceptive failure and unintended pregnancy. The product is packaged in blister packs of 28 tablets: 24 white to off-white tablets containing active ingredients debossed with LU on one side and N81 on the other side and four tablets of inert ingredients debossed with LU on one side and M22 on the other side.


Source: FDA