Cadila recalls over 10,000 bottles of anti-allergy drug in US

New Delhi: Cadila Healthcare is recalling over 10,000 bottles of an anti-allergy drug in the US because of a mix-up in tablets. Zydus Pharmaceuticals USA, a unit of the company, is recalling 10,200 bottles of promethazine hydrochloride tablets that contain foreign tablets, according to information on the US Food and Drug Administration (FDA) website.

The recall is due to the "presence of atenolol 25 mg tablet mixed into promethazine 25 mg tablet bottles," the FDA said. The nationwide recall was initiated on May 8. The 25-mg tablets in 100-count bottles were manufactured by Cadila Healthcare and distributed in the US market by Zydus Pharmaceuticals, it added.

The withdrawal was classified as a Class-II recall, which the FDA defines as "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." Comments from Cadila Healthcare could not immediately be obtained. Cadila Healthcare shares today closed at Rs 931.40 on the BSE, up 0.37 per cent.