slimvictor
Bluelight Crew
- Joined
- Dec 29, 2008
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Healthcare providers should not administer any products labeled as sterile from Main Street Family Pharmacy, LLC, of Newbern, Tennessee, and should quarantine them until further notice, the US Food and Drug Administration (FDA) said today.
The agency said it is working closely with the Centers for Disease Control and Prevention and the Tennessee Board of Pharmacy to investigate reports of 7 adverse events associated with steroid injections compounded by the company.
"The reports of adverse events are all from patients who received preservative free methylprednisolone acetate (80 mg/mL) by injection." the FDA said.
"Clinical information about these patients is pending; at least 1 of these infections appears to be fungal in nature," the agency noted.
An investigation into the exact source of these adverse events is ongoing, "but these cases are associated with a potentially contaminated medication," the FDA said.
As part of the ongoing investigation, the FDA said it will "thoroughly review the sterile practices at Main Street."
cont at
http://www.medscape.com/viewarticle/804774
The agency said it is working closely with the Centers for Disease Control and Prevention and the Tennessee Board of Pharmacy to investigate reports of 7 adverse events associated with steroid injections compounded by the company.
"The reports of adverse events are all from patients who received preservative free methylprednisolone acetate (80 mg/mL) by injection." the FDA said.
"Clinical information about these patients is pending; at least 1 of these infections appears to be fungal in nature," the agency noted.
An investigation into the exact source of these adverse events is ongoing, "but these cases are associated with a potentially contaminated medication," the FDA said.
As part of the ongoing investigation, the FDA said it will "thoroughly review the sterile practices at Main Street."
cont at
http://www.medscape.com/viewarticle/804774
