Out-of-Sequence Packaging Forces Manufacturer to Recall Oral Contraceptives

Lupin Pharmaceuticals Inc. has issued a nationwide recall of 1 lot of its oral contraceptive tablets Mibelas 24 Fe (norethindrone acetate and ethinyl estradiol chewable tablets and ferrous fumarate) because of out-of-sequence tablet packaging and missing expiration and lot information.

A confirmed complaint identified a packaging error, in which the blister was rotated 180 degrees in the wallet, reversing the order of weekly tablet orientation. The error also caused the lot number and expiration date to no longer appear visibly. Tablets taken out of sequence may place the user at risk for contraceptive failure and unintended pregnancy.

The products, which are indicated for the prevention of pregnancy in women who elect to use oral contraceptives, are packaged in blister packs containing 28 tablets, including 24 off-white tablets of active ingredients and 4 placebo tablets.

To date, there have been no reports of adverse events related to the packaging error. Lupin is notifying its distributors and customers, and consumers taking the product are urged to return it to the pharmacy or place of purchase.

Reference

Lupin Pharmaceuticals Inc. announces a nationwide tecall of Mibelas™ 24 Fe (norethindrone acetate and ethinylestradiol 1mg/0.02mg chewable tablets and ferrous fumarate 75 mg) tablets due to out of sequence tablets and missing expiry/lot information [news release]. FDA’s website.https://www.fda.gov/Safety/Recalls/ucm560904.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery. Accessed May 30, 2017.