MUMBAI, July 11 India's Sun Pharmaceutical
Industries Ltd is recalling 41,127 bottles of
antidepressant venlafaxine hydrochloride in the United States
after the drug failed to dissolve properly, the U.S. Food and
Drug Administration said.
The voluntary recall was begun by Sun Pharma's unit Caraco
Pharmaceutical Laboratories Ltd in June, and was classified by
the FDA as Class II, meaning that use of or exposure to the drug
may cause temporary or medically reversible adverse health
"Stability results found the product did not meet the drug
release dissolution specifications," the FDA said in a post on
its website on Friday. (1.usa.gov/1kcMaSF)
Dissolution tests are commonly conducted to help predict how
a drug performs inside the body.
Sun Pharma manufactured the drug at its plant in the western
Indian state of Gujarat. A company spokesman in Mumbai declined
The company's recall of venlafaxine hydrochloride comes
three months after Pfizer Inc said it was pulling
104,000 bottles of the same drug, which the U.S. company sells
under the brand Effexor XR, after a pharmacist reported that one
of the bottles contained a heart drug.
Sun Pharma also began a recall of 200 vials of the
chemotherapy drug gemcitabine in the United States in April due
to a lack of assurance of sterility.
Separately, in January, the company pulled 2,528 bottles of
its generic version of the diabetes drug Glumetza.
(Reporting by Zeba Siddiqui in Mumbai; Editing by Subhranshu