FDA Warns of Thyroid Medication Recall
A powerful tool for treating chronic conditions is medication. It can also help control everything. Blood pressure You may experience persistent pain. Hypothyroidism is one of the most common conditions where prescriptions can be effective. Five people out of 100 The National Institutes of Health (NIH) states that there are more than 12 million Americans living with the condition. This condition is more common in those over 60 than it is in women. You should be aware that the Food & Drug Administration (FDA), has recalled a prescription for thyroid problems due to serious health issues. Find out more about this latest recall of medication.
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FDA announced February 1st that IBSA Pharma Inc. TIROSINTSOL Oral Solution (levothyroxine sodium), had been subject to voluntary recall. The agency has listed the affected batches, along with the NDC numbers and lot numbers, as well as expiration dates, so that consumers can identify them.
According to the agency, doctors recommend TIROSINTSOL as a replacement therapy for hypothyroidism. It is also used to suppress pituitary thyroid hormones, which are part of a series of treatments for certain types and forms of thyroid cancer.
According to the FDA, the medicine is called “a clear, colorless to slightly yellow solution supplied in a 1 milliliter white, non-transparent, unit-dose ampule” Each pouch and box will have the correct dosage strength, as well as a different color for each level.
According to FDA’s recall notice IBSA Pharma Inc. recalled this medication after finding that some lots could have subpotency or a lower dose than what was listed. The company found a slight decrease in levothyroxine sodium levels below 95 percent.
According to the agency patients taking lower dose medications could feel the symptoms of hypothyroidism immediately. “fatigue, increased sensitivity to cold, constipation, dry skin, puffy face, hair loss, slow heart rate, depression, swelling of the thyroid gland and/or unexplained weight gain or difficulty losing weight.”
Long-term, incorrect dosage could cause other problems such as adverse effects upon growth and development, brain function, bone metabolism and reproductive function, emotional state, glucose and lipid metabolism, heart function, heart health, and heart function.
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FDA reports that IBSA Pharma Inc. will be alerting distributors, wholesalers, and healthcare professionals about the recall. The FDA advises people who are currently taking TIROSINTSOL to not stop taking it without speaking with their healthcare provider.
There have been no adverse reactions reported or emergency situations. But anyone taking the medication who feels they’re experiencing problems—including pregnant people, newborn infants, and elderly patients—should contact their doctor or healthcare provider immediately.
IBSA Pharma Inc. can be reached at the hotline, or by email to any patient with questions or concerns.
This is not the first recall of medication. The FDA declared that Dec. 21, 20,22 was the last day of recalls for medication. Lupin Pharmaceuticals had voluntarily recalled four lots of Quinapril tablets, which is an angiotensin-converting enzyme (ACE) inhibitor used to lower blood pressure in patients with hypertension.
According to the agency, testing revealed that the “presence of a nitrosamine impurity,” N-Nitroso–Quinapril is the name given to it. This was well above the Acceptable Daily Intolerance (ADI). People are often exposed to nitrosamines. “water and foods, including cured and grilled meats, dairy products, and vegetables,” They may increase your risk of developing cancer in the future. Patients were told to call their doctor while taking the medication.
The FDA announced that another blood pressure medication was being investigated by authorities on October 24, when it revealed that the FDA has a New Jersey-based source. Aurobindo Pharma USA, Inc. It had issued a voluntary recall of two lots. Hydrochlorothiazide tablets and Quinapril USP 20mg / 122.5mg N-Nitroso–Quinapril was also discovered in this instance. The agency advised patients to continue taking the medication while they contacted their doctor or healthcare provider as soon possible.
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