Drug major Sun Pharma is voluntarily recalling 68,194 bottles of its Venlafaxine Hydrochloride...
Drug major Sun Pharma is voluntarily recalling 68,194 bottles of its Venlafaxine Hydrochloride Extended-Release tablets, used to treat major depressive disorder, in the US market.
As per the information available on the USFDA website, Sun Pharma Global Inc, a unit of 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 Inc, Dubai, it added.
The recall was initiated on September 26 this year.
It has been classified as a ‘Class-II recall’ which FDA defined 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”.
A spokesperson of Sun Pharma declined to comment.
Shares of Sun Pharma closed at Rs 882.45 apiece on the BSE, down 0.46 per cent from previous close.