Sun Pharmaceutical Industries Ltd Recalls 68,194 Bottles Of Anti-Depression Drug In U.S.

November 17, 2014

By Riley McDermid, BioSpace.com Breaking News Editor

Struggling Indian drugmaker Sun Pharmaceuticals said Monday that it is voluntarily recalling 68,194 bottles of a depression drug, sold as Venlafaxine Hydrochloride Extended-Release in the United States.

That news, and rumors that Merck & Co. had terminated a collaboration agreement with Sun Pharma, pushed shares of the company down almost 3 percent in morning trading Monday.

The information was obtained via the U.S. Food and Drug Administration’s website, which said the regulator was recalling the drug for failing "dissolution specification". The recall was originally initiated Sept. 26 but became broader this week as it became clear more product had been impacted.

The tablets are made by Sun Pharma Global Inc, a unit of the company. The 37.5 mg tablets in 30-count bottles and 90-count bottles were manufactured at Halol in Dubai. The Class II recall is defined by the FDA 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".

Sun Pharma declined to comment Monday.