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Second firm recalls drugs in light of meningitis outbreak

By Elise Viebeck - 10/31/12 03:35 PM ET

A second drug compounder recalled its products in the wake of a national meningitis outbreak that has sickened hundreds and killed 29.
 
Ameridose is a sister company of the New England Compounding Center, the pharmacy whose steroid injections have been blamed for the deaths.

In an interview with the Boston Globe, a Food and Drug Administration (FDA) official said no patient infections have been linked to Ameridose products. That official, Janet Woodcock, would not confirm whether the agency has found impurities in Ameridose products, according to the paper. 

Ameridose said in a statement Wednesday that its recall was precautionary.

"During the course of its on-going inspection of our facility, FDA has notified Ameridose that it will be seeking improvements in Ameridose’s sterility testing process," the company said.

"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."

Congress, now in recess, has been pushing for answers on the wave of meningitis cases for weeks.

The outbreak has raised questions about compounding pharmacies, firms that reprocess drugs on a large scale to fit patients' needs but are not obligated to follow many rules that apply to drug makers.

Several House Democrats have either introduced or promised legislation that would strengthen federal oversight of drug compounders.


Source:
http://thehill.com/blogs/healthwatch/public-global-health/265145-second-firm-recalls-drugs-in-light-of-meningitis-outbreak

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