The Food and Drug Administration (FDA) yesterday said that 420 batches of 23 ranitidine drug products that allegedly contain the potentially carcinogenic n-nitrosodimethylamine (NDMA) must be recalled by Nov. 18.
The impurity was not intentionally added to the drugs by the manufacturers, but was found in the active pharmaceutical ingredients, the FDA said, adding that the source of the impurity remained unclear and was being investigated in several countries.
As part of normal monitoring of international drug safety information last month, the FDA discovered that some ranitidine drugs — used to treat and prevent ulcers in the stomach and intestines — were being voluntary recalled because NDMA was detected.
Photo courtesy of the Food and Drug
As NDMA is classified as a likely human carcinogen, it launched an inspection to test ranitidine products from multiple domestic manufacturers, the FDA said.
Thirty-eight permits for ranitidine products from 21 manufacturers have been approved by the FDA, and they were all asked to conduct their own laboratory testing to assess NDMA levels in their products and report the results to the agency within a month, it said.
As of Friday, the FDA had received reports for 15 products, or 287 batches, with those products approved to continue distribution and sales, FDA Medicinal Products Division section chief Hung Kuo-teng (洪國登) said.
The remaining 23 products must be recalled before Nov. 18, Hung said, adding that some of them contained NDMA exceeding the allowable limit, some did not turn in the report before the deadline and some were voluntarily recalled by the manufacturer.
A list of the products and batch numbers that have been recalled can be found on the FDA’s official Web site, www.fda.gov.tw, under the “stomach medicine abnormal events information” section on the Chinese-language main page.
Due to the volume of items affected by the recall, it is difficult to estimate totals for each product, Hung said.
Most of the recalled drugs were removed from shelves last month and there are alternative drugs that treat the same symptoms, so people do not need to worry, he said.
They should consult a doctor if they want to stop taking the drug or switch to an alternative, he said.
Additional reporting by staff writer, with CNA
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