Sun Pharma recalls 40,000 bottles
pharmafile | July 14, 2014 | News story | Manufacturing and Production | Caraco Pharmaceutical Laboratories, FDA, Pfizer/Wyeth’s Effexor XR, Sun Pharma, antidepressant, recall
India-based manufacturer Sun Pharmaceutical Industries is recalling more than 40,000 bottles of its antidepressant venlafaxine hydrochloride, the US regulator has reported.
It is the second time this year that such a problem with the drug has occurred: the Food and Drug Administration said the product “did not meet the drug release dissolution specifications”, suggesting there were problems with it dissolving in the bodies of patients.
Distributed by Sun’s US arm, Detroit-based Caraco Pharmaceutical Laboratories, it was made at Sun’s facility in Gujurat, India. 26,530 bottles containing 30 pills and 14,597 with 90 in them are now being recalled.
The drug is a generic version of Pfizer/Wyeth’s Effexor XR – formerly a multi-billion dollar seller – which was the subject of an unrelated voluntary recall in March over worries that one bottle contained a capsule of heart drug Tikosyn (dofetilide).
Venlafaxine hydrochloride is a serotonin-norepinephrine reuptake inhibitor (SNRI), a class of drugs targeting chemicals in the brain which may become unbalanced and cause depression, and which is used to treat major depressive disorder, anxiety and panic disorder.
This is a class II recall under the FDA’s designation, which means that exposure to the pills “may cause temporary or medically reversible adverse health consequences” but the probability of serious adverse health consequences is ‘remote’.
In a class I recall, death would be the probable result of taking the affected drug, while a class III is for recalls where health problems are ‘not likely’.
Sun Pharma has been no stranger to the nuances of the FDA’s classification system this year, recalling 252,000 bottles of venlafaxine as part of a recall of almost 400,000 bottles of medications in the US in May.
Again, this was because the pills failed to dissolve properly: the other offender was antihistamine Cetirizine, 128,000 bottles of which were taken off the market because they “may not meet the drug release specification through expiry”.
Indian firms have had an unhappy time of it lately, facing increased scrutiny from US authorities concerned that the quality of drugs made in that country are not up to scratch.
FDA commissioner Margaret Hamburg went to India in February to meet with pharma manufacturers to discuss production problems, and to attempt to shore up quality.
But in March the US imposed a ban on imports from a division of Sun, saying that the unit was not “operating in conformity with good manufacturing practices”.
Overall the FDA has put more than 30 Indian manufacturing units on its ‘import alert’ list, something that can stop products from entering the US.
Adam Hill
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