The Food and Drug Administration (FDA) yesterday recalled 1.077 million Epilramate film-coated tablets after an inspection found that several batches of the medicine contained insufficient amounts of its main ingredient.
Two batches of Epilramate 25mg film-coated tablets (batch Nos. 190441 and 210466) and two batches of Epilramate 100mg film-coated tablets (batch Nos. 210467 and 210471) are to be withdrawn from the market, the agency said.
FDA medicinal product division specialist Hsu Chih-yu (許芷瑀) said that the main ingredient of the medicine is topiramate, which is primarily used for adjuvant treatment of partial epilepsy in adults and children over two, as well as epilepsy with Lennox-Gastaut syndrome or primary generalized tonic-clonic epilepsy.
Photo courtesy of the Food and Drug Administration
The medicine can be administered to treat people with partial-onset seizures or to prevent migraine.
“During the ongoing stability tests of the medicine, TWi Pharmaceuticals found that the amount of the main ingredient in the two types of tablets was 94 percent, below the 95 percent and 105 percent approved by FDA respectively,” Hsu said. “The impurities in the two types of tablets were 0.33 percent and 0.54 percent respectively, which also exceed the FDA standard of 0.25 percent.”
“As the medical effects might be compromised due to the errors, we have asked TWi Pharmaceuticals to recall the two types of tablets by Dec. 2,” she said.
Photo courtesy of the Food and Drug Administration
The National Health Insurance system last year covered the cost of 120,000 Epilramate 25mg tablets and 320,000 100mg tablets, its database showed.
TWi was also required to submit a report detailing the recall process as well as subsequent corrective measures, Hsu said.
Medical institutions and pharmacies across the nation should comply with the recall efforts, she said, adding that people who have taken the medicine should consult their doctors if they have doubts.
Separately, more than 80 percent of the medical institutions in the nation are expected to resume normal nuclear medicinal services this week following an emergency request to increase the domestic supply of technetium-99, the FDA said.
The global supply of technetium-99, a radioactive isotope commonly used in imaging, was disrupted by an unexpected mechanical failure of a BR2 nuclear reactor in Belgium last week. Due to a foreseeable shortage of the substance, hospitals have suspended or postponed exams in their nuclear medicinal departments.
FDA medicinal product section chief Yang Bo-wen (楊博文) said that technetium-99 is a key substance used in the imaging of the thyroid and salivary glands, as well as heterotopic gastric mucosa and tear ducts.
The government has issued permits to five suppliers to import the regulated substance. Three of the suppliers have reported supply shortages.
Yang said that it is difficult to gauge domestic demand for technetium-99, adding that the FDA has asked the importers to increase the supply of the substance.
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