OEP Philippines Inc. initiated voluntary recall of Nicorandil
According to the Food and Drug Administration, OEP Philippines Inc. initiated a product recall of specific batches of Nicorandil (Aprior) 5 mg and 10 mg tablets. Nicorandil was used in the manufacture of Aprior 5mg and 10mg by Hizon Laboratories Inc. The products were distributed by Zuellig Pharma Corporation.The tablets are used to treat angina pectoris. Angina pectoris is the medical term for chest pain or discomfort due to coronary heart disease. It occurs when the heart muscle doesn't get as much blood as it needs due to the narrowing of one or more of the heart's arteries. The drug helps maintain the blood flow to the heart and helps prevent angina pain from occurring.
The recall covered batches with registration numbers DR-XY35217 and DR-XY31195 in response to the statement of non-compliance with Good Manufacturing Practice issued by the Italian Medicines Agency to Societa Italiana Medicinali Scandicci, the manufacturer of the active pharmaceutical ingredient Nicorandil.