A packaging error caused a pharmaceutical company in Baltimore to announce a recall of a popular medication – birth control pills. The error could potentially lead to unwanted pregnancy.
Lupin Pharmaceuticals, Inc. manufactures the product. The pills are sold under the brand name Mibelas 24 Fe. They were distributed to wholesalers, clinics and retail pharmacies across the country before the company announced the recall.
According to the U.S. Food and Drug Administration, the tablets were oriented the wrong way inside the box. This could cause a consumer to take placebo pill for the first four days of treatment, instead of taking the active tablets.
The FDA explained, “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 reversing [of] the 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.”
The FDA’s report went on to say, “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.”
So far, there have been no reports of consumers experiencing any adverse side effects from the recalled birth control pills. The Mibelas 24 Fe package contain 28 pills total. The 24 active contraceptive pills are labeled “N81” while the four placebo pills are labeled “M22.”
Lupin Pharmaceuticals sent letters to distributors and customers to notify them of the recall. Costumers who purchased the recalled products should contact their health care provider and return the pills. Questions about the recall can be directed to Lupin at 1-800-399-2561 from 8:00 AM to 5:00 PM Monday through Friday.
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Sources:
Opposing Views
U.S. Food and Drug Administration
Lupin Pharmaceuticals, Inc.
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