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Source: http://www.cidrap.umn.edu/cidrap/content/other/news/oct3112fungal.html
FDA probe prompts recall from second compounding pharmacy
Lisa Schnirring * Staff Writer
Oct 31, 2012 (CIDRAP News) ? A second compounding pharmacy today recalled all of its products in the wake of Food and Drug Administration (FDA) investigations surrounding a multistate fungal meningitis outbreak linked to contaminated injectable steroids.
Ameridose, based in Westborough, Mass., said in a statement that during the FDA's ongoing inspection of its facility, the agency notified the company that it will ask for improvements in its sterility testing process. Ameridose said it hasn't received any adverse events reports related to the recalled products, and testing by the company and the FDA have turned up no contamination in the products.
"Nevertheless, out of an abundance of caution, we are undertaking this recall to assure customers that when Ameridose products are shipped, they are fully in conformance with all of the FDA's recommendations," the company said in its statement.
Meanwhile, the fungal meningitis outbreak total grew by 14 cases today, along with 1 more death, according to the latest update from the US Centers for Disease Control and Prevention (CDC). The additional cases push the national count to 377 cases and 29 deaths.
Two more peripheral joint infections were reported, boosting that total to nine. The number of affected states remained the same, at 19.
The outbreak infections have been linked only to tainted methylprednisolone acetate injections from one compounding pharmacy, New England Compounding Center (NECC), based in Framingham, Mass. Ameridose is one of two NECC sister companies that the FDA and the Massachusetts Department of Public Health are also investigating. The other is Alaunus Pharmaceuticals, also based in Framingham.
Ameridose's recall notice was also distributed today by the FDA. The company asked its customers to immediately examine their inventories and separate out the Ameridose products. It urged facilities to complete forms on the current status of the products, along with their names and lot numbers.
The recall notice doesn't specify the volume of recalled products, but noted that Ameridose will soon post a complete list of recalled products on its Web site.
According to Ameridose's Web site, the company offers more than 2,200 sterile intravenous and prefilled oral syringe solutions, mainly to hospitals, and is registered as a manufacturer with the FDA and the Drug Enforcement Agency. Third-party labs registered by the FDA handle the company's stability testing, which covers potency, sterility, pH, and particulate matter, according to the company's background information.
See also:
Oct 31 Ameridose statement
Oct 31 FDA recall notice
Ameridose company background
Oct 31 CDC outbreak update
FDA probe prompts recall from second compounding pharmacy
Lisa Schnirring * Staff Writer
Oct 31, 2012 (CIDRAP News) ? A second compounding pharmacy today recalled all of its products in the wake of Food and Drug Administration (FDA) investigations surrounding a multistate fungal meningitis outbreak linked to contaminated injectable steroids.
Ameridose, based in Westborough, Mass., said in a statement that during the FDA's ongoing inspection of its facility, the agency notified the company that it will ask for improvements in its sterility testing process. Ameridose said it hasn't received any adverse events reports related to the recalled products, and testing by the company and the FDA have turned up no contamination in the products.
"Nevertheless, out of an abundance of caution, we are undertaking this recall to assure customers that when Ameridose products are shipped, they are fully in conformance with all of the FDA's recommendations," the company said in its statement.
Meanwhile, the fungal meningitis outbreak total grew by 14 cases today, along with 1 more death, according to the latest update from the US Centers for Disease Control and Prevention (CDC). The additional cases push the national count to 377 cases and 29 deaths.
Two more peripheral joint infections were reported, boosting that total to nine. The number of affected states remained the same, at 19.
The outbreak infections have been linked only to tainted methylprednisolone acetate injections from one compounding pharmacy, New England Compounding Center (NECC), based in Framingham, Mass. Ameridose is one of two NECC sister companies that the FDA and the Massachusetts Department of Public Health are also investigating. The other is Alaunus Pharmaceuticals, also based in Framingham.
Ameridose's recall notice was also distributed today by the FDA. The company asked its customers to immediately examine their inventories and separate out the Ameridose products. It urged facilities to complete forms on the current status of the products, along with their names and lot numbers.
The recall notice doesn't specify the volume of recalled products, but noted that Ameridose will soon post a complete list of recalled products on its Web site.
According to Ameridose's Web site, the company offers more than 2,200 sterile intravenous and prefilled oral syringe solutions, mainly to hospitals, and is registered as a manufacturer with the FDA and the Drug Enforcement Agency. Third-party labs registered by the FDA handle the company's stability testing, which covers potency, sterility, pH, and particulate matter, according to the company's background information.
See also:
Oct 31 Ameridose statement
Oct 31 FDA recall notice
Ameridose company background
Oct 31 CDC outbreak update