US subsidiary of Indian drug major recalls 68,194 bottles of anti-depressant venlafaxine hydrochloride, a third recall for the drug since March
Sun Pharma Global Inc, a unit of Sun Pharmaceutical Industries, has initiated recall of 68,194 bottles of anti-depressant venlafaxine hydrochloride in the US and Puerto Rico after the drug failed to dissolve properly.
In a notification by the US Food and Drug Administration, it said Sun Pharma Global Inc, Dubai, has initiated recall of venlafaxine hydrochloride extended-release tablets, 37.5 mg, 30-count bottles and 90-count bottles. The prescription-only drug is manufactured at Sun's plant in Halol, Gujarat, for Sun Pharma Global Inc Dubai, UAE due to "failed dissolution specification".
Dissolution tests are commonly conducted to help predict how a drug performs inside the body.
This is a Class II recall, which means use/exposure to the drug may cause temporary or medically reversible adverse health consequences, according to FDA.
This is the third recall of this drug from Sun Pharma since March this year. Sun Pharma's US subsidiary Caraco Pharmaceutical Laboratories had earlier in March recalled 2,51,882 bottles of the same drugs for a similar dissolution failure. In June, the company again initiated recall of 41,127 bottles of the anti-depressant drug.
In both the earlier cases, the drugs were manufactured at the company's Halol facility, which in September this year underwent an FDA inspection. Post inspection, FDA has issued Form 483 since there were some procedural issues, if not data integrity issues, with that facility. There were 23 observations with 10 for the injectable unit, four for the oral solid unit and the rest for the quality control lab. The facility is estimated to be contributing nearly 20-25% of Sun's profits.
A Form 483 is issued by FDA to a company's management at the conclusion of an inspection done on a company's facility when an investigator(s) has observed any conditions that in their judgement may constitute violations of the Food Drug and Cosmetic (FD&C) Act and related Acts.
In the Form 483, the US drug regulator found that there was no formalised corrective action plan in regards to the earlier recalls of venlafaxine ER.
A Sun Pharma spokesperson declined to comment. While the Halol facility is operational, the management had said during the second quarter results earnings call recently that it is working on the observations made by the FDA on the unit.
According to a pharma analyst, while the impact may not be severe for Sun Pharma immediately but such examples of frequent recalls sets a bad precedence. "The recent FDA inspection at Halol was looked as an after-effect of various recalls by Sun in the US market. Indian companies should be more careful while dealing with the FDA and the US market," the analyst said.
){kind=small}
){kind=small}
){kind=small}
){kind=small}
){kind=small}
){kind=small}
){kind=small}
){kind=small}
){kind=small}
){kind=small}
){kind=small}
){kind=small}
){kind=small}
){kind=small}
){kind=small}
){kind=small}
){kind=small}
){kind=small}
)
){kind=small}
){kind=small}
){kind=small}
){kind=small}
)
){kind=small}
){kind=small}
)
)
)
)
)
){kind=small}
){kind=small}
){kind=small}
){kind=small}
){kind=small}