KNOXVILLE (WATE) – A mix-up in packaging has led to a voluntary recall of Mibelas 24 Fe.
Lupin Pharmaceuticals Inc. issued a voluntarily recalled for Mibelas 24 Fe (Norethindrone Acetate and Ethinyl Estradiol 1 mg/0.02 mg chewable and ferrous fumarate 75 mg). The recall impacts 28-day packs and three-wallet cartons with the lot number L600518 and expiration May 31, 2018.
The U.S. Food and Drug Administration said their packaging was rotated 180 degrees, placing four of the placebo pills ahead of the 24 white active tablets. If taken out of order, women could have an increased risk of pregnancy.
If the person does become pregnant, the FDA notes that the birth control the other tablets in the recalled birth control could hurt the fetus’ health and in some cases cause death.
The product was distributed nationwide. Lupin is notifying its distributors and customers by recall letter and is arranging for return of all recalled products.
This is not the first time there has been a birth control mix-up. In 2015 a lawsuit was filed that claimed 113 women became pregnant after a similar packaging error from another company.
Previous story: Lawsuit: Birth control mix-up results in 113 pregnancies
What to look for
Anyone concerned about their package of Mibelas 24 FE should take a close look at the pills and compare them to previous ones.
A close examination would reveal the different-colored pills in an odd orientation. The four darker placebo tablets are at the beginning of the 28-day cycle, instead of the at the end of the 24 white pills.
The FDA says because of the packaging mistake the lot numbers and expiration are not visible. This is another indicator. The National Drug Code for the affected pills, which should be visible, are 68180-911-11 for the wallet of 28 tablets and 68180-911-13 for a carton of three wallets.
They 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.
Anyone with a questionable pack should return it to the pharmacy immediately. Anyone with questions can call 1-800-399-2561, 8:00 am to 5:00 pm EST, Monday through Friday. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking this drug product.
Adverse events or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting Program either online or by calling 1-800-332-1088 to request a paper reporting form.