The Food and Drug Administration (FDA) issued a warning about the recall of thousands of Tydemy brand birth control pills manufactured by Lupin Pharmaceuticals.
The recall comes after Lupin Pharmaceuticals discovered that two batches of the contraceptive tablets may have lower effectiveness in preventing pregnancy. This potential risk has raised concerns among patients and healthcare providers alike.
Lupin Pharmaceuticals Recalls Thousands of Tydemy Birth Control Pills
According to NBC News, the FDA's warning has raised their concerns as it reveals that Tydemy birth control pills, a combination prescription contraceptive containing estrogen and progestin, may not be as effective as intended. Pharmaceutical manufacturers commonly conduct what is known as "stability" testing to verify the quality and effectiveness of their medications until their expiration dates.
According to Lupin Pharmaceuticals, batches of Tydemy experienced deficiencies, specifically insufficient levels of an inactive component known as ascorbic acid, which is used in the manufacturing process.
The recall specifically targets two lot numbers, affecting a total of 4,179 boxes, or approximately 350,000 tablets, distributed nationwide to pharmacies and supermarkets between June 2022 and May 2023.
Lupin Pharmaceuticals, the drugmaker behind Tydemy, has taken proactive measures by voluntarily recalling the affected batches at the wholesale level.
The company discovered that the two batches fell short after 12 months, exhibiting lower levels of an inactive ingredient, ascorbic acid, used in the tablet's production, along with a higher concentration of a known impurity. This combination could potentially reduce the product's effectiveness and lead to unexpected pregnancies, according to Lupin's statement.
According to the FDA, for individuals who have been using Tydemy birth control pills from the affected lots, it is crucial to check the packaging for lot numbers L200183 and L201560. These lots were distributed between June 3, 2022, and May 31, 2023, and have expiration dates of January or September 2024.
Potential Impact on Lupin Pharmaceuticals
While the current recall of Tydemy birth control pills has not been linked to any adverse events, the FDA urges individuals currently using the recalled lots to continue taking their medication. However, they should promptly consult their healthcare providers to explore alternative contraceptive methods.
It remains unclear what caused the "out of specification" issue, and there are concerns that additional batches might also be impacted.
As per CBS, the recall of Tydemy birth control pills is not the first setback for Lupin Pharmaceuticals. In a similar incident last year, the company recalled batches of the blood pressure medication Quinapril due to the discovery of impurities.
Furthermore, an inspection of one of Lupin's facilities unveiled several shortcomings, including an insufficient investigation of "out of specification" test results. The recurrent issues raise questions about the company's quality control measures and may affect its reputation as a leading pharmaceutical firm.
The recall of thousands of Tydemy brand birth control pills has raised concerns about the effectiveness of the contraceptive and potential risks to users.
Patients are urged to stay informed, follow the FDA's guidelines, and consult with their healthcare providers to ensure they are using safe and effective contraceptive methods. As the situation unfolds, the focus will be on how Lupin Pharmaceuticals addresses the issue and implements measures to prevent similar incidents in the future.
