US drugmaker Viatris was yesterday ordered to recall two batches of Norvasc, a high blood pressure drug, as the Food and Drug Administration (FDA) said iron wires were found in samples taken from the shipment.
The recall applies to 6 million Norvasc 5mg tablets from batches FR3135 and FT2343, the agency said, adding that it ordered the company to complete the recall by Jan. 29.
The active agent in Norvasc is amlodipine besylate, which inhibits the movement of calcium ions across cardiac muscles and the lining of blood vessels.
Photo courtesy of the Food and Drug Administration via CNA
The recall order came after the Consumers’ Foundation last month held a news conference to detail complaints from local long-term users of Norvasc.
FDA Medicinal Products Division head Hung Kuo-teng (洪國登) cited users of the drug as telling the event that they had found wires in the tablets when breaking them in half.
The FDA has launched an investigation and asked Viatris to provide information about the drug, Hung said.
This led to the identification of the FR3135 batch, he said, adding that the FDA suspected that the other batch might also be affected and recalled it as well.
Hung said that with about 210 million tablets sold last year, Norvasc accounted for about 60 percent of its segment in the local high blood pressure drug market.
The FDA also ordered Viatris to submit a report on the incident and detail measures it would take to ensure that the issue does not occur again, Hung said.
Norvasc users who are affected by the recall and want to change to an alternative medication should consult a doctor before doing so, the FDA said.
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