US recalls 350,000 birth control pills that may be ineffective
Hundreds of thousands of birth control pills have been recalled in the US after being found to possibly not work in stopping pregnancy.
The US Food and Drug Administration (FDA) on Tuesday announced that Lupin Pharmaceuticals Inc is voluntarily recalling two lots of Tydemy.
‘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,’ states a company announcement on Saturday.
About 350,000 tablets across 4,179 boxes are under recall for potentially being less effective in preventing pregnancy, according to an FDA database.
The affected lots have the following figures printed at the side of the package: L200183 and L201560.
Tydemy was distributed across the US to drug stores, pharmacies, supermarkets and wholesalers. They were distributed over nearly a one-year period, from June 3, 2022, to May 31, 2023.
The company to date had ‘received no reports of adverse events’ linked to the batches under recall.
‘Lupin advises patients to continue taking their medication. Patients should immediately contact their health care provider for advice regarding an alternative contraceptive method,’ stated the company announcement.
‘Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.’
The drugmaker is offering reimbursements for the recalled product.
Lupin is the third largest pharmaceutical company in America based on prescription numbers.
The company in December recalled batches of Quinapril, a medication to treat high blood pressure, after discovering some impurities.
In addition, a facility run by Lupin that underwent an inspection in March was found to have shortcomings, with FDA inspectors writing that ‘deviation investigations are not thoroughly investigated by your firms and appropriate actions are not taken to prevent recurrence’.
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