Sun Pharmaceuticals hit with recall of over 31 thousand bottles of anti-depressants
pharmafile | October 13, 2016 | News story | Business Services, Manufacturing and Production, Medical Communications, Research and Development, Sales and Marketing | FDA, India, US, america, sun pharmaceutical
Sun Pharmaceuticals have been forced to recall 31,762 bottles of anti-depressants from the US market after the FDA issued a ‘Class III’ recall over dissolution issues. The drug in question, buproprion hydrochloride, delivered in ‘extended-release tablets’, failed ‘dissolution specifications’.
The dissolution specification relates to the speed at which the drug breaks down in the body. With a solid pill, dosage depends on release of the drug substance from the product. The pharmaceutical companies are responsible for overall quality of the product via testing drug release characteristics. The anti-depressant tablets are manufactured by Sun Pharma at its Halol plant, which had previously received an FDA warning.
The bad news is compounded by the previous recall of 12,109 bottles of Cardeviol tablets used for the treatment of high blood pressure due to “failed impurities/degradation specifications” at the end of September.
It has had such an impact because the US pharmaceutical market makes up half of the company’s consolidated revenue. It is the largest Indian pharmaceutical company in the US and the fifth largest speciality generic pharmaceutical company in the world. Any loss of confidence in the US market could then drastically hurt the company’s fortunes. The fact that Sun Pharma voluntarily withdrew their product, though under advice of the FDA, and the recall was not classified as Class I or II, which are far more serious, should be noted. In response to the cumulative bad news for Sun Pharma their shares have begun to dip as of late.
Ben Hargreaves
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