Friday, November 2, 2012

Products from Mass. company recalled from local medical facilities

By Nick Tabor, New Era Senior Staff Writer
The Massachusetts company blamed for the meningitis outbreak had systemic problems with sterilization in its drug lab, state inspectors found.
Two Hopkinsville facilities, plus others throughout Kentucky and Tennessee, have been using products from the company — though mostly not the ones that cause meningitis. The U.S. Food and Drug Administration released an exhaustive list this week of the company’s customers.
The manufacturer, New England Compounding Center, has recalled all its products. So Jennie Stuart Medical Center has ceased using a muscle relaxant it produced, called Robaxin, and has notified all 73 patients who have received the drug since May.
The FDA has not reported any illnesses associated with Robaxin. Jennie Stuart’s letter to patients described the recall as a precautionary measure, according to a hospital news release.

Additionally, Western Kentucky Institute of Plastic, Reconstructive and Aesthetic Surgery sent back all the antibiotic cream it purchased from the company.
“We’re always very careful,” said Susan Valentini, the institute’s office manager said.
She added that the cream doesn’t enter a patient’s pores when a doctor uses it. It’s simply a numbing agent, and since it gets cleaned off after surgery — and never injected — it never posed any threat.
Altogether, 45 facilities in Kentucky used products from NECC. This includes Western Baptist Hospital in Paducah, Pain Management Center of Paducah, Owensboro Dermatology and The Medical Center at Bowling Green.
In Tennessee, 64 facilities used NECC’s products, including Gateway Medical Center in Clarksville and more than a dozen in the greater Nashville area.
NECC voluntarily halted operations on Oct. 3, after patients across the U.S. who had received its epidural steroid injections started contracting meningitis. So far 328 people in 18 states have reported cases of meningitis, and 24 have died, the Centers for Disease Control and Prevention reported on Wednesday. This includes five cases and one death in Kentucky.
Massachusetts’ Department of Public Health has been investigating NECC throughout October. Inspectors have found dirty lab equipment, failures to maintain important sterilization tools, and a leaking boiler and dirty mat near the room where sterile medications were produced, according to state records. NECC could lose its pharmacy license.

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