The Food and Drug Administration (FDA) yesterday announced a recall of 10,000 doses of the antibiotic Targocid, a drug used to treat infective endocarditis.
Hung Kuo-teng (洪國登), the head of the FDA’s Medicinal Products Division, said Targocid 400mg for Injection, produced in batch 1J5721 by French multinational pharmaceutical company Sanofi, is the target of the recall.
The FDA said that about 10,000 doses from that batch has been distributed throughout Taiwan. All doses identified should be returned by March 6.
Photo: AFP
Clinics, hospitals and pharmacies have been asked to stop prescribing the drug and contact anyone known to have been prescribed the drug, Hung said.
Sanofi voluntarily notified the FDA in October last year that problems might have arisen on the drug’s production line, he said.
The FDA asked the company for more information, and was told that the batch in question was slightly contaminated with a water soluble corticosteroid known as methylprednisolone hemisuccinate.
The corticosteroid is used to relieve a number of ailments such as severe allergic reactions, respiratory diseases and nervous system conditions.
About 120,000 doses of Targocid are prescribed annually under Taiwan’s national health insurance program, accounting for 80 percent of the market for drugs of the same nature made with the same active ingredients and dosage, Hung said.
However, patients who rely on the medication should not be concerned that a recall might cause a shortage of the drug, as Taiwan has enough other brands offering the same active ingredient, he said.
The FDA recommended that people concerned about the issue should visit a doctor to discuss alternative medications.
Targocid’s primary application is for the treatment of infective endocarditis caused by staphylococcus.
Secondary applications include the treatment of osteomyelitis, pneumonia, sepsis, soft tissue infection and small intestine inflammation.
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