27 June 2014 | Regulatory | By BioSpectrum Bureau
Wockhardt recalls its hypertension drug in the US
Singapore: Drug major Wockhardt has decided to recall over 8,000 bottles of anti-hypertension drug Metoprolol Succinate extended-release tablets in the US market. The decision was taken after the capsules failed a dissolution test. The bottles were manufactured by Mumbai based Wockhardt Ltd. and distributed in the US market by Wockhardt USA Inc.
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.