Contraceptive pills recalled because they may not work, warns the FDA
New tests indicate that this medication could be ineffective.
Most of us trust that the drugs that have been prescribed are supposed to help us. But sometimes, even our doctors cannot predict what problems could arise on the road, this is where the Food and Drug Administration of the United States (FDA) comes into play, because the agency continuously warns consumers of any problem affecting the drugs they can take. In February, the FDA revealed that a Popular thyroid drugs had been recalled due to resistance to the list dose less than the list. Then in April, the agency alerted us from a Major reminder Impact on 80 prescription and over -the -counter drugs (OTC) because their safety could not be guaranteed. Now the FDA warns that a new prescription problem could endanger more people. Read the rest to find out more about the reasons why certain contraceptive pills are recalled because they may not work.
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The FDA has just alerted consumers of a new reminder of medication.
If you take birth control, you may want to pay attention to a new FDA warning. In a July 31 press release , the agency alerted consumers to a major medication recall. According to the press release, Lupine Pharmaceuticals Inc. now remembers some of its Tydemy tablets at the consumer level.
"Tydemy is an oral estrogen / progestogen contraceptive (COC) indicated for use by women to prevent pregnancy and increase folate levels in women who choose to use an oral contraceptive for contraception", explained the company in his reminder ad.
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Lupine remembers two lots of Tydemy.
Lupine Pharmaceuticals Inc. is one of the largest pharmaceutical companies in the United States based on total prescriptions. The company recalls two lots of Tydemy which have been distributed nationally to "wholesalers, drug channels, correspondence and supermarkets", according to the announcement. It is therefore likely that many people could be affected. AE0FCC31AE342FD3A1346EBB1F342FCB
"Tydemy is packed in a bulb of 28," said Lupine. "Such a bulb was then packed in a pocket with a printed sleeve, a pack insert (with day label) and a bag of oxygen absorber (stabilix). The three sachets were wrapped in a box."
The contraceptive pills recalled have an UPC of 368180904731 and were distributed between June 2022 to May 2023. The affected packages may include one of the two numbers of lots: L200183, which expires in January 2024, and L201560, which expires in September 2024 .
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These contraceptive pills may not work.
The two lots of Tydemy are recalled due to the results of the tests excluding specification (OOS) at the stability of 12 months. OOS results include " All test results which do not fall under specifications or acceptance criteria established in drug applications, drug files (DMFS), official Compendia or by the manufacturer ", according to the FDA.
With its tests, it has been found that one of the lots of Tydemy recalled (L200183) tested weak for ascorbic acid inactive and high for known impurity - which could make the contraceptive pills essentially ineffective. "Lupine remembers these two lots because if there was a significant reduction in the quantity of inactive content (ascorbic acid), this could potentially have an impact on the effectiveness of the product which could potentially cause unexpected pregnancy", explained the company in its ad.
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You should talk to your doctor if you take this medication.
Wholesalers, distributors and retailers who have one of the products recalled, many Tydemy are invited to interrupt their sale immediately. But if you are currently taking these contraceptive pills, you should always do it until you talk to your doctor.
"Patients who take Tydemy are invited to continue to take their medication and immediately contact their pharmacist, doctor or medical supplier to obtain advice on alternative treatment," said Lupine.
The company has not yet received a report of undesirable events linked to one or the other of the lots of Tydemy. But "consumers must contact their doctor or health care provider if they have encountered problems that may be linked to taking or using this drug product," added Lupine in his ad.
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