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National Recall of Birth Control Pills; Out of Sequence Tablets; Contraception Failure


On May 25, 2017, Lupin Pharmaceuticals Inc. recalled lot L600518, Exp 05/18 of Mibelas 24 Fe (Norethindrone Acetate and Ethinyl Estradiol 1 mg/0.02 mg chewable and ferrous fumarate 75 mg) Tablets. A confirmed market complaint indicated a packaging error, where the blister was rotated 180 degrees within the wallet, reversing the weekly tablet orientation and making the lot number and expiration date no longer visible. The first four days of therapy would have had four non-hormonal placebo tablets as opposed to the active tablets.

 

As a result of this packaging error, oral contraceptive tablets that are taken out of sequence may place the user at risk for contraceptive failure and unintended pregnancy. The packaging error may not be apparent to either new users or previous users of the product, increasing the likelihood of taking the tablets out of order. For patients in whom a pregnancy is contraindicated or in whom concomitant medication(s) may have teratogenic effects, an unintended pregnancy may cause significant adverse maternal or fetal health consequences, including death.

 

This product is an oral contraceptive indicated for the prevention of pregnancy in women who elect to use oral contraceptives. These products are packaged in blister packs containing 28 tablets: 24 white to off-white tablets of active ingredients debossed with “LU” on one side and “N81” on the other; and 4 tablets of inert ingredients debossed with “LU” on one side and “M22” on the other side. This product was distributed nationwide in the U.S. to wholesalers, clinics, and retail pharmacies.

 

See the Recall

 

See also Medical Law Perspectives Report: The New Oral Contraceptives: Stroke and Other Adverse Event Liability

 

See also Medical Law Perspectives Report: Drugs, Dosage, and Damage: Physician Liability for Prescribing or Administering Medication

 

 

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