The Food and Drug Administration (FDA) has upgraded the recall of over 54,000 bottles of a commonly used thyroid medication due to concerns over low potency. As of October 6, 2023, the agency announced a Class II recall for 54,432 bottles of levothyroxine sodium tablets, which are essential for individuals with thyroid hormone deficiencies.
The recall affects tablets administered in doses of 88 mcg, or 0.088 milligrams, with each bottle containing 90 tablets. The agency’s notice indicated that these products were distributed by Accord Healthcare Inc., located in Raleigh, North Carolina, while the manufacturing was carried out by Intas Pharmaceuticals Ltd., based in India.
Details of the Recall
According to the FDA, the recall was initiated voluntarily by Accord Healthcare after discovering that the affected products did not meet the required potency levels. A Class II recall indicates that the use of the product may cause temporary or medically reversible adverse health consequences. The FDA urges consumers who have these tablets to return them to the place of purchase or dispose of them properly.
Levothyroxine sodium is widely prescribed for treating hypothyroidism, a condition where the thyroid gland does not produce enough hormones. Patients relying on this medication may experience symptoms such as fatigue, weight gain, and depression if the potency is insufficient.
The FDA’s announcement underscores the importance of adhering to pharmaceutical standards, ensuring that medications remain effective and safe for public use. The agency continues to monitor the situation and advises healthcare providers to inform patients of the recall and discuss alternative treatment options.
Patients with concerns regarding their medication or health conditions are encouraged to consult their healthcare providers for guidance.
