WASHINGTON, April 10 The U.S. Food and Drug Administration has announced the recall of glass bottles of Grifulvin V (griseofulvin oral suspension), a fungal medication.
The FDA said the 125 mg/5mL bottles of the prescription medicine used to treat ringworm and other fungal infections are being voluntarily recalled as a precaution based on two reports of glass fragments found in bottles of the liquid formulation.
The voluntary recall is being conducted by Ortho-McNeil Pharmaceuticals Inc., but the bottles carry a Patriot Pharmaceuticals LLC label. The voluntary recall is limited to the liquid formulation of the medication and does not include any other dosage form.
The FDA said the glass fragments are believed to be the result of bottle breakage during shipping and handling.
Consumers who believe they are in possession of the recalled griseofulvin oral suspension can call 1-800-510-0383 for further information or return the product to their pharmacy.
The affected lot numbers are posted at www.aboutgrifulvin.com.
Copyright 2007 by UPI
