The company is recalling the drug for failing dissolution specification
Sun Pharma has decided to recall 68,194 bottles of its Venlafaxine Hydrochloride Extended-Release tablets, an anti-depression in the US. The company is recalling the drug for failing "dissolution specification". The 37.5 mg tablets in 30-count bottles and 90-count bottles, were manufactured by Sun Pharmaceutical Industries at Halol for Sun Pharma Global, Dubai.
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.