Anti-hypertension drug Amlodipine Besylate tablets recalled by Cadila in the US market
Cadila Healthcare Ltd is recalling 5,144 bottles of the drug Amlodipine Besylate tablets in the US market. According to the information available on the USFDA website, Zydus Pharmaceuticals USA Inc., the US-based arm of the company, is recalling the drug due to "discoloration". According to the US FDA regulator, “Brown spots were noted embedded in Amlodipine Besylate Tablets, 10 mg, leading to discoloration and thus recall.
The anti-hypertension drug, Amlodipine Besylate tablets were manufactured by Cadila Healthcare and distributed by Zydus Pharmaceuticals USA Inc. The tablets are indicated to lower the blood pressure. The nationwide recall has been initiated by the company on October 1 this year on account of brown spots found embedded in Amlodipine Besylate Tablets, 10 mg. The recall has been initiated under class III which FDA defined as "a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences".
Zydus Cadila is headquartered in Ahmedabad and has global operations in USA, Europe, Japan, Brazil, South Africa and 25 other emerging markets. Their products range from APIs (Active Pharmaceuticals to animal health products and cosmeceuticals.