According to medicines for africa (mfa) reports, the recall was due to the presence of N-Nitroso Carvedilol I impurity, a cancer-causing impurity, above the recommended acceptable intake limit following a recent testing of the product by the United States FDA which indicated that N-Nitroso Carvedilol I was present in the product above the Acceptable Daily Intake (ADI) level.
💡 Nitrosamines are common in water and foods, including cured and grilled meats, dairy products and vegetables. Everyone is exposed to some level of nitrosamines. These impurities may increase the risk of cancer if people are exposed to them above acceptable levels over long periods of time.
Healthcare professionals are advised to provide other alternatives for their patients taking carvedilol manufactured by New Jersey-based Glenmark Pharmaceuticals Inc.
The East Africa Regulatory Affairs professionals Association (EARAPA) verified that the manufacturer of the product, Glenmark Pharmaceuticals Inc. has many registered products in many African countries.