Medication Recall Alert

April 11, 2007

ISSUE:	FDA announces recall of griseofulvin oral suspension due to two reports of glass fragments found in bottles of the liquid formulation
MEDICATION:	Grifulvin V® (griseofulvin), Ortho-McNeil Pharmaceuticals

The following was excerpted from the FDA Med Watch alert website dated April 10, 2007:
"Ortho-McNeil and FDA informed healthcare professionals and consumers of a nationwide recall of griseofulvin oral suspension, a prescription medication used to treat ringworm and other fungal infections. The recall was issued based on two reports of glass fragments found in bottles of the liquid formulation. The recall is limited to the liquid formulation of the medication and does not include any other dosage form. Consumers in possession of the medication should contact the pharmacy where they purchased the drug to determine if they have the product that has been recalled and direct medical questions to their healthcare professional."

An excerpted accompanying FDA statement is as follows:

"Glass bottles of griseofulvin oral suspension (liquid) [GRIFULVIN V®], microsize 125 mg/5mL, a prescription medicine used to treat ringworm and other fungal infections, are being voluntarily recalled as a precaution from wholesalers and retail pharmacies nationwide. The voluntary recall is a precaution based on two reports of glass fragments found in bottles of the liquid formulation. Consumers who believe they are in possession of recalled product should contact the pharmacy where the medicine was purchased.

The voluntary recall is being conducted by Ortho Dermatological, Division of Ortho-McNeil Pharmaceutical, Inc., manufacturer of GRIFULVIN V® and griseofulvin oral suspension, which has a Patriot Pharmaceuticals, L.L.C., label. This voluntary recall is limited to the liquid formulation of the medication and does not include any other dosage form.

The two reports of glass fragments are believed to be the result of bottle breakage during shipping and handling. 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, and action is being taken to change the over-wrap to prevent this possible occurrence in the future. In the unlikely event that a damaged bottle has been dispensed, a potential exists for injury due to accidental ingestion of glass fragments. There have been no reports of adverse events from the reported glass fragments in broken bottles.

In addition to contacting the pharmacy where the medicine was purchased, consumers who believe they are in possession of recalled bottles of GRIFULVIN V® griseofulvin oral suspension (liquid) may also call 1-800-426-7762. Consumers who believe they are in possession of affected product from Patriot Pharmaceuticals, LLC, griseofulvin oral suspension (liquid), may call 1-800-510-0383. Consumers should direct medical questions to their health care providers. Adverse reactions experienced with the use of this product should be reported to the company using the telephone numbers above. The company is voluntarily conducting this recall in cooperation with the U.S. Food and Drug Administration and sending urgent recall letters to wholesalers and pharmacies nationwide. In addition, the company is taking action to supply new inventory to its customers.

Additional recall information and Lot numbers.