Signage is seen outside the U.S. Food and Drug Administration headquarters in White Oak, Maryland, Aug. 29, 2020.
Andrew Kelly | Reuters
The U.S. Food and Drug Administration has warned that some Tydemy contraception pills might not be effective, several days after the manufacturer recalled two batches of the medication that were distributed within the U.S.
The FDA said the pills in query could end in unexpected pregnancy. The agency has not received any reports of hostile events related to Tydemy to date.
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The manufacturer, Lupin Pharmaceuticals, announced a voluntary recall of two batches of Tydemy on July 29. The pills in those batches were distributed within the U.S. between June 3, 2022, and May 31, 2023.
Lupin, in a statement last week, said it recalled the batches because pills in a single batch tested low for ascorbic acid and “high for a known impurity.” The corporate said a big reduction in ascorbic acid could affect the product’s effectiveness.
Lupin said it’s notifying wholesalers, distributors, drug chains and supermarkets of the issue and is working to get the affected pills off store shelves. Any store, distributor or wholesaler that has the affected pills in stock should immediately stop distributing them, the corporate said.
The batches of Tydemy that might not be effective come from lot numbers L200183 and L201560.
Lupin advised patients to proceed taking their medication and immediately seek the advice of with their doctor about an alternate type of contraception.