The Epoch Times – 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” …
