Recall - Ameridose, sister company of New England Compounding Center (NECC) issues recalls on all of its productsNovember 6, 2012 | Category: Defective Drugs | Share
According to an Food & Drug Administration (FDA) press release October 31, 2012, Ameridose, Westborough, MA, sister company of the New England Compounding Center, Framingham, MA linked to more than 30 deaths caused by contaminated products, informed its customers of its voluntary recall of all of its products following the FDA's inspection which found "shortcomings in testing procedures". The FDA has called for improvement in Ameridose's sterility testing process.
Drug recalls are classified as "voluntary" or "mandatory" under the FDA's regulations. The FDA, in an effort to secure the support of drug manufacturers and/or their channel of distribution members will make a request that a voluntary recall be issued. This is what happened with Ameridose.
In the event that the manufacturer, or channel distribution members, do not agree to issue a voluntary recall, there are provisions for the FDA to issue mandatory recalls.
Ameridose is licensed in all 50 states and sells over 2,200 products to hospital pharmacies. Their products are predominantly injectable drugs used in critical care
and in anesthesia among other ways. These products include: antagonistis, antibiotics, anticholinergics, anticonvulsants, antiemetics, electrolytes, general anesthetics, heparin, local anesthetics, neuromuscular blocking agents, pain management, sedatives, tranquilizers and vasopressors.
The Associated Press on November 1, 2012 reported that Ameridose's own company records during the first half of 2012 showed that "33 surface samples from the clean rooms (where the company produced sterile injectable medications) contained bacteria or mold at levels requiring corrective action."
Attorney Randall Spivey, Spivey Law Firm, Personal Injury Attorneys, P.A., reminds patients they have the right to know what drugs are being used in the their treatment and also have the right to request a list of those drugs. Having this information may help reduce anxiety.
If you or a family member has suffered injuries or death due to a dangerous or defective product, please contact our experienced Product Liability Injury Attorney Team.
Randall L. Spivey is a Board Certified Civil Trial Attorney – the highest recognition for competence bestowed by the Florida Bar and a distinction earned by less than 2 percent of Florida attorneys. He has handled over 1,500 personal injury and wrongful death cases throughout Florida. For a free and confidential consultation to discuss your legal rights, contact the Spivey Law Firm, Personal Injury Attorneys, P.A., at 1.888.477.4839, or by email to Randall@SpiveyLaw.com. Visit SpiveyLaw.com for more information.