Pharmaceutical firm Sanofi Taiwan Co has agreed to recall a batch of heart disease medicine due to possible contamination, the Food and Drug Administration (FDA) said yesterday.
The FDA said in a statement that it had received a report about suspected contamination in Tritace 10mg tablets with the batch number U322, as dark spots were found on some tablets.
The FDA said it had asked Sanofi Taiwan to investigate the possible contamination and ascertain whether other batches were affected, and the company said it was willing to issue a preventive recall of the whole batch.
Photo courtesy of the Food and Drug Administration
A preliminary investigation suggests that the dark spots might be dried human blood from workers who might have had small wounds on their hands and wore broken gloves while operating machines during the manufacturing process, the company said.
The agency first received reports about the contamination on Oct. 11, FDA Medicinal Products Division section head Hung Kuo-teng (洪國登) said.
Similar incidents, such as tablets being contaminated by lubricants during production, have occurred in other countries before, Hung said, adding that the firm has decided to send the recalled tablets to a manufacturing plant in another nation for further examination.
However, FDA data showed that about 1.3 million tablets in batch number U322 were imported and sold by September, so the number of consumed tablets was unknown, he said.
Sanofi Taiwan would be required to recall the entire batch of drugs by Jan. 9, he added.
Tritace is mainly used to treat hypertension and post-myocardial infarction heart failure, as well as to prevent cardiovascular disease in people who are at greater risk, the FDA said, adding that people who are taking the drug should continue taking the medication and consult a doctor if they are concerned.
Medical professionals and consumers should report any adverse reactions or serious problems due to medications by calling the FDA’s hotline (02-2396-0100) or through its Web site, adr.fda.gov.tw, it said.
Additional reporting by CNA
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