Written by
Walter F. Roche Jr.
The Tennessean
Yet another drug compounding company that holds a license to sell its
products in Tennessee is recalling all of its sterile injectable drugs
after federal inspectors found evidence of bacterial contamination in
one of its products.
The recall announced Sunday by the U.S. Food and Drug Administration is being conducted by Balanced Solutions Compounding of Lake Mary, Fla. Among the products being recalled are vials of methylprednisolone acetate, the same spinal steroid blamed for a nationwide fungal meningitis outbreak that has killed 15 Tennessee residents and sickened more than 150.
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The recall announced Sunday by the U.S. Food and Drug Administration is being conducted by Balanced Solutions Compounding of Lake Mary, Fla. Among the products being recalled are vials of methylprednisolone acetate, the same spinal steroid blamed for a nationwide fungal meningitis outbreak that has killed 15 Tennessee residents and sickened more than 150.
Continue to read here
1 comment:
supposedly there are complaints out there (but since the complaint process is confidential, no one knows for sure).
If you noticed the last Florida Board of Pharmacy meeting minutes - the Board consistently "rejected the proposed Settlement Agreements" and then amended them to make the terms harsher (such as - we'll let you voluntarily relinquish your license and not pay more lawyers to fight us when we try revoking your license).
The problem is not the Boards of Pharmacy (or the Boards of Medicine, etc.) It's the Department of Health "state employees" who often do "good enoough for government work", who haven't been diligent during the inspection process (letting obvious violations go without citation or punishment), and offer ridiculously light Settlement Agreements (plea bargains), so they won't have to do the work to prosecute cases.
Kenneth Woliner, MD
www.holisticfamilymed.com
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