The Michigan Attorney General’s Office is seeking a license suspension for a South Lyon pharmacy recently linked to the distribution of tainted injections.
An administrative complaint was filed Tuesday against pharmacist Kenny R. Walkup Jr., and his operation Specialty Medicine Compounding Pharmacy. Attorney General Bill Schuette filed the complaint in conjunction with Steve Arwood, the director of the Department of Licensing and Regulatory Affairs.
Schuette also moved to suspend Walkup’s controlled substance license.
According to the complaint, Henry Ford Hospital notified the Food and Drug Administration on Oct. 17 after they found multiple vials of unexpired dextrose injections, which were a green and brown color. Tests showed the injections contained two types of mold and fungus.
“There is the potential that products received by Michigan facilities have been contaminated,” the complaint says. “Respondent allowed an adulterated product to be shipped to Michigan health facilities leading to an imminent public health threat in the State of Michigan as it is unknown how many products were contaminated and administered to patients.”
Because of the amount of the drug produced, it is believed Walkup was producing the drugs before his manufacturing license had been approved, court documents say. The complaint also questions whether Walkup’s facility is a sterile environment.
Walkup issued a voluntary recall of the tainted products on Oct. 19. The products were distributed to hospitals and individual consumers across the state beginning July 1. For a complete list of the recalled products, visit http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts.
“Michigan citizens trust pharmacists to follow the laws designed to keep consumers safe,” Schuette said in a statement. “As soon as the tainted drugs were reported, we moved swiftly to protect public safety and welfare, and we have launched an official investigation to determine whether additional civil or criminal action is warranted.”
The complaints come amid a massive review of state regulations for compounding pharmacies after a meningitis outbreak linked to New England Compounding Center in Massachusetts.
The pharmacy is alleged to be behind 264 infections and 19 deaths in Michigan, according to the most recent data available from the Centers for Disease Control and Prevention and the Michigan Department of Community Health.
lrazzaq@detroitnews.com
(313) 222-2127
(313) 222-2127
From The Detroit News: http://www.detroitnews.com/article/20131031/METRO06/310310091#ixzz2jK7k3cWW
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