The Taiwan Food and Drug Administration (FDA) announced Wednesday that it will recall 300,000 Amvlo Film-Coated Tablets 5/160mg that are used to treat high blood pressure after a stability test of the drug yielded low dissolution results, which is likely to affect their efficacy.
The FDA initiated the recall mechanism after receiving information from Everest Pharm. Industrial Co., which manufactures the drug, that three batches of the drug with the designations T0304105, T0304609, and T0304710 were defective, said Hung Kuo-teng (???), head of the FDA’s Medicinal Products Division.
The low dissolution of the problematic tablets means that they would provide insufficient dosages, which is likely to undermine their efficacy, he said.
The three batches are to be recalled by Everest by Jan. 19, Hung said.
The pharmaceutical company will have to deliver a report on the recall and how similar incidents could be prevented in the future, he said.
The recall is unlikely to result in a shortage of generic medication with the same ingredients and dosage currently available on the market, he said.
People should seek medical help if they have any doubts about the medications they are taking, so that physicians could prescribe appropriate alternatives, he said.
Source: Focus Taiwan News Channel