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Lupin Pharmaceuticals Inc. recalled lot L600518, expiry 05/18 of Mibelas 24 Fe (norethindrone acetate and ethinyl estradiol 1 mg/0.02 mg and ferrous fumarate 75 mg) chewable tablets. The blister pack was unintentionally rotated 180 degrees during the packaging process. Inactive tablets were packaged instead of active tablets for the first 4 days in the blister pack. The packaging error also obscures the lot number and expiration date on the blister pack. Consumers may identify out of sequence packages by the lack of a lot number or by inspection of tablet order. Active tablets are white to off-white debossed with “LU” and “N81” on either side. Inactive tablets are brown debossed with “LU” and “M22” on either side. The correct sequence of tablets is 24 active tablets followed by 4 inactive tablets.
Out of sequence administration of oral contraceptives may increase the risk of contraceptive failure and unintended pregnancy. Adverse effects to the mother or fetus, including death, are possible in cases of unintended pregnancy in patients taking concomitant teratogenic medications or if pregnancy is contraindicated. So far, no such events have been reported. Report any adverse events to the FDA MedWatch Adverse Event Reporting Program. Return affected medication to the place of purchase. Contact the prescribing physician in case of incorrect administration.
Additional Information:
- MedWatch Safety Alert – May 29, 2017
www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm560908.htm - Lupin Pharmaceuticals Inc. Press Release – May 25, 2017
www.fda.gov/Safety/Recalls/ucm560904.htm