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Certain lots of the prescription birth control pill Tydemy may be less effective than expected, potentially resulting in an unintended pregnancy, because the pills do not contain enough of an active ingredient.
The U.S. Food and Drug Administration warned consumers about the issue Tuesday following a company announcement about the issue on July 29.
Lots L200183 and L201560, in 28-dose blister packs, were distributed throughout the United States between June 3, 2022, and May 31, 2023.
"To date, Lupin has received no reports of adverse events related to either recalled batches," the company noted. "Regardless, Lupin is recalling these two batches because if there were a significant reduction in the amount of inactive content (ascorbic acid), this could potentially impact the effectiveness of the product which could potentially result in unexpected pregnancy."
Patients should continue taking their medication, the FDA said, but they should also immediately contact their health care provider for advice about an alternative method of birth control.
The company had previously voluntarily recalled the two lots of Tydemy at the wholesale level.
"Consumers, wholesalers, distributors, and retailers with questions regarding this recall should contact Inmar Rx Solutions, Inc. at (866) 480-8206 Monday – Friday 9:00 a.m. to 5:00 p.m. EST," Lupin instructed in its statement. "For reimbursement, please have the recalled lots returned to Inmar Rx Solutions, Inc.; the lot number can be found on the side of the carton."
The FDA also encouraged health care providers and patients to report any adverse events or quality problems with this or other medications to the agency's MedWatch Adverse Event Reporting program.
SOURCE: U.S. Food and Drug Administration, Aug. 1, 2023
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