Showing posts with label Compounder issues nationwide recall of 45 products FDA has inspected 56 of the largest compounding pharmacies August 6. Show all posts
Showing posts with label Compounder issues nationwide recall of 45 products FDA has inspected 56 of the largest compounding pharmacies August 6. Show all posts

Tuesday, August 6, 2013

Compounder issues nationwide recall of 45 products FDA has inspected 56 of the largest compounding pharmacies August 6, 2013 | By Eric Palmer


Even as other regulatory concerns have moved to the forefront, the FDA has continued its inspection march through the country's largest compounding pharmacies, seeking recalls from those it finds lacking.
The latest recall is from Beacon Hill Medical Pharmacy, which operates under the name of Rxtra Solutions. It is recalling all lots of 45 different products after the FDA "raised a question of sterility assurance" for products from the Southfield, MI, facility. The company said it has not received any reports of adverse reactions. The list of products includes everything from compounded versions of diazepam to vials of testosterone.
This year the FDA started a campaign to quickly inspect the largest compounding pharmacies, facilities that operate more like small drug manufacturers, often shipping products nationwide. The action tracks back to last year's outbreak of fungal meningitis that infected hundreds, dozens fatally. The outbreak was traced to drugs made by New England Compounding Center, which has since closed up shop. Inspections of it and and a sister business found serious issues around sterility. 
Read more: Compounder issues nationwide recall of 45 products - FiercePharma Manufacturing http://www.fiercepharmamanufacturing.com/story/compounder-issues-nationwide-recall-45-products/2013-08-06#ixzz2bDpI7uMu
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