The Food and Drug Administration upgraded the recall of a type of commonly used thyroid medication due to low potency issues, according to a
notice posted by the agency.
The agency said that 54,432 bottles of levothyroxine sodium tablets are being recalled because of sub-potency and upgraded the recall to Class II on Oct. 6. The prescription-only tablets come in 88 mcg, or 0.088 milligram, amounts at 90 tablets per bottle, the notice said.
They were distributed by Accord Healthcare Inc. of Raleigh, North Carolina, and manufactured by Intas Pharmaceuticals Ltd., based in India, according to the FDA. The firm voluntarily initiated the recall, the agency said.
According to a
section on the FDA website, a Class II drug recall occurs when there is “a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”
Earlier this year, the FDA
confirmed a recall of 160,630 bottles of levothyroxine sodium tablets that were also made by Intas Pharmaceuticals due to potency issues. In that recall, which was also listed as Class II by the agency, multiple batches of levothyroxine in different potencies were impacted.
Intas was also subject to several FDA
import alerts in 2022 and 2023 after U.S. officials had inspected a company factory in India and found “significant violations.”
“Because your methods, facilities, or controls for manufacturing, processing, packing, or holding do not conform” to the agency’s manufacturing standards, the company’s “drug products are adulterated,” the FDA said in its two letters to the company.
A letter that was
sent to the company’s chief executive by the FDA noted that Intas manufactures a number of other drugs including several types of cancer treatment drugs and chemotherapy medications.
Levothyroxine sodium is used to treat hypothyroidism, which is when the thyroid gland doesn’t produce enough hormones. The drug can be used as a form of hormonal replacement therapy to boost thyroid levels,
according to health officials.
“This medicine is also used to help decrease the size of enlarged thyroid glands (also called a goiter),” the Mayo Clinic says on its website. “Levothyroxine is also used together with surgery and radioiodine treatment to treat a type of thyroid cancer called thyroid-dependent well-differentiated thyroid cancer,”
A database used to track drug prescriptions, ClinCalc,
shows that around 80 million estimated prescriptions were filled out for levothyroxine sodium in 2023, making it the third most commonly prescribed medication.
In a separate instance earlier this year, the FDA
confirmed that it also has concerns about “the safety and effectiveness” of some “unapproved animal-derived” medications used to treat thyroid problems that haven’t been reviewed by the FDA.”
“Tablets made from the same manufacturing batches may not always provide the same thyroid hormone levels. Inconsistent doses can have serious consequences for patients. Too much medication can cause unwanted effects, and too little could not be effective,” it said, without providing additional details.
The Epoch Times contacted Intas Pharmaceuticals for comment on Thursday. The company has not publicly responded to the FDA’s claims.
