Tablets may be Taken Out of Sequence and Are Missing Expiry/Lot Information
Mibelas 24 Fe birth control pills have just been recalled due to a packaging error that may lead to unwanted, unexpected pregnancies. The pills are sold under the name of Mibelas 24 Fe and contain Norethindrone Acetate and Ethinyl Estradiol 1 mg/0.02 mg chewable and ferrous fumarate 75 mg.
To achieve maximum contraceptive effectiveness, Mibelas 24 Fe must be taken exactly as directed. Patients are instructed to take one tablet by mouth and at the same time each day. The Mibelas tablet may be chewed and swallowed or swallowed whole. The patient is advised to drink a full glass-eight ounces-of water immediately after the Mibelas tablet is chewed or swallowed whole. Tablets must be taken in the order directed on the wallet pack and should not be skipped or taken at intervals exceeding 24 hours.
The recalled Mibelas 24 Fe birth control pills are manufactured by Lupin Pharmaceuticals, according to TheRealFact24.com. The birth control pills were packaged in a wrong order. The U.S. Food and Drug Administration (FDA) pointed out that the first four days of tablets that are labeled as active pills were, in fact, non-hormonal placebo pills. After a woman takes these wrongly packaged pills, she will not receive the correct hormone dosage to prevent conception, which could then lead to an unwanted, unexpected pregnancy. “This product is an oral contraceptive indicated for the prevention of pregnancy in women who elect to use oral contraceptives,” according to the FDA.
The Mibelas 24 Fe birth control pills involved in the recall were distributed across the United States to wholesalers, clinics, and retail pharmacies. The recalled Mibelas 24 Fe birth control pills bear the lot number L600518 and an expiry date of May 31, 2018. The birth control package contains 28 tablets with 24 white to off-white tablets that contain active ingredients and are debossed with the letters “LU” and the letter-numbers “N81” on either side. The package also contains four tablets of inert ingredients-the placebo pills-that are debossed with the letters “LU” on one side and the letter-numbers “M22” on the other side. Along with inserting the pills in wrong order, the packaging error also made the lot number and expiration date “no longer visible,” according to TheRealFact24.com.
The recall applies to one lot and two National Drug Codes (NDC) packages. The NDCs are 68180-0911-13 (carton of three wallets) and 68180-0911-11 (wallet of 28 tablets). The impacted lot began shipping on March 15, 2017.
The FDA wrote that, “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.” Affected consumers are advised to report to the nearest clinic immediately and consult a doctor. The pills may be returned to the pharmacy or to the place from where the birth control pills were originally purchased.
Parker Waichman LLP has spent decades representing clients in drug injury lawsuits. The firm continues to offer free legal consultations to individuals with questions about filing a Mibelas 23 Fe unexpected pregnancy lawsuit.
Mibelas 23 Fe Recall Background
The GoodRx Prescription Savings Blog noted that Lupin Pharmaceuticals issued a voluntary recall and notes that Mibelas 23 Fe is one of several generic alternatives for the brand name drug Minastrin 24 Fe, which is a chewable birth control pill that comes with iron supplements.
The FDA has deemed the recall a Class I, which is the agency’s most serious type of recall and means that the recall involves a situation in which there is a reasonable probability that use of the recalled medication may cause serious adverse health consequences or death. A manufacturer may voluntarily recall its medication with the knowledge of the agency, which is the case with these recalled birth control pills. The FDA may also request or mandate that a manufacturer recall a particular medication. The FDA notes that, “When a company announces a recall, market withdrawal, or safety alert, the FDA posts the company’s announcement as a public service. FDA does not endorse either the product or the company.”
On May 25, 2017, the drug maker, Lupin, initiated a recall over the packaging error. One blister in the recalled packages was rotated by 180 degrees. This rotation reversed the weekly tablet orientation, making the lot number and expiration date no longer visible. Also, in the affected lot, the first four pills in the monthly pack are non-hormonal placebo tablets instead of active tablets that contain medicine.
An unintended pregnancy may cause significant adverse consequences for maternal or fetal health, which may include death in patients for whom a pregnancy is contraindicated, or for those patients who are taking other medication(s) that may have teratogenic effects. Teratogenic effects are adverse reactions that may disrupt the development of an embryo.
Because of the error, patients may have trouble locating the lot and NDC information on their prescriptions as the lot number and expiration date are not easily visible. Also, according to the GoodRx Prescription Savings Blog, regardless if a patient has been prescribed Mibelas 24 Fe previously or if the patient is taking the drug for the first time, it would be impossible to determine if the tablets were in reverse order, increasing the risk that a patient might take a placebo tablet when a hormonal tablet should be taken and vice versa.
The FDA noted that Lupin is advised its distributors and customers by recall letter and arranging for return of all recalled products.
Filing a Mibelas 23 Fe Unexpected Pregnancy Lawsuit
If you or someone you know is interested in filing a personal injury lawsuit involving Mibelas 23 Fe and an unexpected pregnancy, contact Parker Waichman today. Our firm offers free, no-obligation case evaluations. For more information, fill out our online form or call 1-800-YOURLAWYER (1-800-968-7529).