PHOTO from fda.gov.ph
MANILA, Philippines—A pharmaceutical firm has voluntarily recalled from the market a drug used in the treatment of ischaemic heart disease due to non-compliance with the recommended guidelines for the manufacture and sale of drug and active pharmaceutical products.
In an advisory, the Food and Drug Administration (FDA) said OEP Philippines Inc. was initiating a product recall of specific batches of Nicorandil (Aprior) 5mg and 10mg tablet with registration numbers DR-35217 and DR-XY31195.
“[The product recall] is in response to the statement of non-compliance with Good Manufacturing Practice issued by the Italian Medicines Agency to Societa Italiana Medicinali Scandicc, srl, (SIM), the manufacturer of the active pharmaceutical ingredient, Nicorandil,” stated the FDA.
It further said Nicorandil was used in the manufacture of Aprior 5mg and 10mg by Antipolo-based Hizon Laboratories Inc. The products were distributed by Zuellig Pharma Corporation.
Nicorandil is a medicine used to treat angina, a pain that stems from the heart usually caused by the narrowing of the coronary arteries. The drug helps maintain the blood flow to the heart and helps prevent angina pain from occurring.
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