The Ahmedabad-based Cadila Healthcare is voluntarily recalling 5,400 bottles of anti-hypertension drug Atenolol tablets in the US for failing to meet specifications. According to a notification by the US Food and Drug Administration (USFDA), the recall of the 5,400 bottles has been voluntarily initiated by the company through its US based arm Zydus Pharmaceuticals USA Inc.
"The company has initiated the recall, which falls under Class II, as a complaint was reported by a pharmacist who stated several tablets were noticeably thicker in appearance," USFDA said.
According to the US health regulator, Class II recall is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
The drugs were manufactured by Cadila Healthcare and distributed in the US by Zydus Pharmaceuticals USA Inc.
Comments from the company could not be obtained immediately.
"The company has initiated the recall, which falls under Class II, as a complaint was reported by a pharmacist who stated several tablets were noticeably thicker in appearance," USFDA said.
According to the US health regulator, Class II recall is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
The drugs were manufactured by Cadila Healthcare and distributed in the US by Zydus Pharmaceuticals USA Inc.
Comments from the company could not be obtained immediately.