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Sun Pharma is recalling more than 216,000 bottles of felodipine blood pressure tablets and the antidepressant imipramine because the varnish on labels is leaching a chemical into the containers. The news comes on the heels of a July recall of bupropion hydrochloride tablets made at Sun’s Halol, Gujarat, India, plant. Read More
Seattle Genetics received a six-observation Form 483 from the FDA for documentation and adverse event reporting failures related to its only approved product — cancer drug Adcetris. Read More
Drugmakers in the EU have less than seven months to conduct risk assessments of all the excipients they use under good manufacturing practices guidelines imposed by the European Commission. Read More
Indian active pharmaceutical ingredient maker Pan Drugs Limited was hit with an FDA warning letter after an inspection revealed data integrity issues and significant cGMP violations, leading the company to announce it would sell its product locally. The company will stay on the FDA’s Import Alert list until it makes the corrections. Read More
Early notice of production shutdowns by manufacturers of life-supporting and life-sustaining drugs and biologics have allowed the FDA to avert more than 550 potential drug shortages in the last three years, the agency says in a final rule mandating early notice. Read More
The FDA is questioning Mylan’s ability to achieve overall GMP compliance at three injectables manufacturing plants in India after finding serious deviations that should have been corrected after the drugmaker acquired Agila in December 2013. Read More
Seattle Genetics received a six-observation Form 483 from the FDA for documentation and adverse event reporting failures related to its only approved product — cancer drug Adcetris. Read More
Contract manufacturer Pernix Manufacturing received an 11-observation Form 483 for a litany of cGMP violations, including failing to investigate complaints about caterpillars and poppy seeds in vials of finished product. Read More
Pfizer’s Dalian, Liaoning, China, facility received a six-observation Form 483 for retesting failed samples, poor record controls and using an open pit for a urinal. Read More