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ROCKVILLE, Md. -- The FDA said two reports of glass fragments in a liquid antifungal triggered a nationwide recall of griseofulvin (Grifulvin V), microsize 125 mg/5mL.
ROCKVILLE, Md., April 11 -- The FDA said two reports of glass fragments in a liquid antifungal triggered a nationwide recall of griseofulvin (Grifulvin V), microsize 125 mg/5mL.
The agency said that there have been no reports of adverse events from the reported glass fragments in bottles of the medicine, which is used to treat ringworm and other common fungal infections.
Ortho Dermatological, Division of Ortho-McNeil Pharmaceutical, Inc., manufacturer of both the Grifulvin V brand and a generic formulation sold under the Patriot Pharmaceuticals label, is conducting the voluntary recall.
The FDA said the recall was limited to the liquid formulation of the medication and does not include any other dosage.
The two reports of glass fragments were believed to be the result of bottle breakage during shipping and handling.
The FDA said a plastic over-wrap placed on bottles of this medicine for protection might have made it difficult to detect breakage that occurred during shipping and handling. As result, the FDA said, action is being taken to change the over-wrap to prevent this possible occurrence in the future.
The agency warned that consuming medicine from a damaged bottle was associated with risk for injury because of accidental ingestion of glass fragments.
The lots were shipped to distributors in the U.S. only from Aug. 23, 2005 through March 14, 2007. Lot numbers were posted on www.aboutgrifulvin.com. Lot numbers can be found on the back of the product label only on four-ounce (120 mL) glass bottles filled by the manufacturer.
Consumers with bottles that were filled at the pharmacy and do not contain lot numbers should get in touch with the pharmacy where they purchased the medicine to determine whether they are in possession of product that has been recalled.
The FDA said Ortho-McNeil was also sending urgent recall letters to wholesalers and pharmacies nationwide. In addition, the company said it was taking action to supply new inventory to its customers.