Lupin Pharmaceuticals is voluntarily recalling birth control pills because of a packaging error that may result in unintended pregnancy. There was a reversal in the placement of the pills that rendered the lot number and the expiration date illegible. The pills are marketed and sold under the name of Mibelas 24 Fe. They contain Norethindrone Acetate and Ethinyl Estradiol 1 mg/0.02 mg. chewable and ferrous fumarate 75 mg. manufactured by Lupin.
The packaging error occurred when the blister was rotated 180 degrees within the wallet, reversing the weekly tablet order 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 instead of the active tablets, according to the U.S. Food and Drug Administration (FDA). The four non-hormonal placebo tablets were therefore, incorrectly placed at the beginning of the sequence, pushing the active tablets back, reports CBS News. Everything that is supposed to be in the blister pack is there, it is just in the wrong place, officials say.
The FDA says, “The reversing order may not be apparent to either new users or previous users of the product, increasing the likelihood of taking the tablets out of order. 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.”
For patients where a pregnancy is contraindicated or in whom accompanying medications may have teratogenic effects. Teratogenic effect is when a drug or other substance is able to interfere with the development of a fetus potentially causing birth defects. For these patients, an unintended pregnancy may cause significant adverse maternal or fetal health consequences, including death. Currently there have been no reports of such adverse events.
National law firm Parker Waichman LLP has extensive experience and success representing clients in pharmaceutical litigation. Attorneys at the firm are available to answer questions for any individuals seeking legal information for a potential lawsuit.
The product has been distributed across the United States to the wholesalers, clinics, and retail pharmacies. The recalled product has the lot number L600518 and with the expiration date of May 31, 2018, contained 28 tablets: 24 white to off-white tablets of active ingredients debossed with “LU” and “N81” on either side; and four tablets of inert ingredients debossed with “LU” on one side and “M22 on the other side. Along with inserting the pills in incorrect order, the packaging mistake also made the lot number and expiration date “no longer visible,” reports THE REAL FACT 24.
It is recommended that all affected consumers report to the nearest clinic immediately and consult a physician. Lupin is notifying its distributors and customers by recall letter and is arranging for return of all recalled products, notes the FDA.
How Birth Control Pills Work
Birth control pills work by releasing the hormones progestin and (usually, but not always) estrogen, which prevent the eggs from getting to the fallopian tubes, where they otherwise could be fertilized. Most contraceptive pills also make it harder for eggs to attach to the uterus and for sperm to reach them. For these hormones to do their job, the pills are taken containing them every day for three weeks, reports Teen Vogue.
Then, placebo pills are taken, which don’t contain any hormones. This is not physically necessary, but some people find it easier than remembering to skip their birth control pills each month, and the hormones have already worked to prevent ovulation.
Typically, placebo pills are taken during the last week of each package’s use, but if one of these packages that were incorrectly packed, and the consumer took the pills in the order they normally do, the pills have been taken too soon. To ascertain whether the mix-up is from a package affected by the error, check if the four that read “M22” on one side instead of “N81” is there. A close examination would reveal the different-colored pills in an odd orientation. It is explained that “the four, darker placebo tablets [are] at the beginning of the 28-day cycle, instead of at the end after the 24 white pills.”
Unintended pregnancy could cause devastating consequences for women, including teens who may be taking birth control pills. Serious medical consequences may also result for some women who have been told not to get pregnant for medical reasons.
Legal Help Regarding Pharmaceutical Errors
If you or someone you know has been injured by medication errors, you may be eligible for valuable compensation. The personal injury attorneys at Parker Waichman LLP offer free, no-obligation case evaluations. We urge you to contact us at 1-800-YOURLAWYER (1-800-968-7529).