A pharmaceutical company in Baltimore announced a recall of birth control pills due to a packaging error that could potentially lead to unwanted pregnancy.
The product in question is manufactured by Lupin Pharmaceuticals, Inc. and sold under the brand name Mibelas 24 Fe. It was distributed across the country to wholesalers, clinics and retail pharmacies.
The U.S. Food and Drug Administration (FDA) wrote on its website May 25 that, due to a packaging mistake in which the tablets were oriented the wrong way inside the box, a consumer would be taking placebo pills for the first four days of treatment rather than active tablets.
"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 FDA explained in its report. "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."
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The report went on to state: "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."
As of May 25, there were no reports of consumers experiencing any of these adverse effects.
The Mibelas 24 Fe package contains a total of 28 pills: 24 with active contraceptive ingredients stamped "N81" and four placebos with inert ingredients stamped "M22." The placebo pills are designed to be taken later on in the course of treatment.
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Lupin has sent letters to distributors and consumers notifying them of the recall. Customers who purchased the recalled product are urged to contact their health care provider and return the tablets to the place of purchase.
Anyone with questions about the recall can reach Lupin at 1-800-399-2561 from 8:00 a.m. to 5:00 p.m. EST, Monday through Friday.
On its website, Lupin identifies itself as "the U.S. wholly owned subsidiary of Lupin Limited, which is among the top five pharmaceutical companies in India."
"Through our sales and marketing headquarters in Baltimore, MD, Lupin Pharmaceuticals, Inc. is dedicated to delivering high-quality, branded and generic medications trusted by healthcare professionals and patients across geographies," the website states.