Ortho-McNeil Pharmaceutical, Inc. is recalling glass bottles of GRIFULVIN V(R) griseofulvin oral suspension (liquid) due to glass fragments found in some bottles. The recall is only for the liquid form of the drug. Consumers should call their pharmarcy to see if their prescription is included in the recall.
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.
The lots were shipped to distributors in the United States only between August 23, 2005 and March 14, 2007. Lot numbers are listed at the end of this press advisory and posted on http://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 pharmacy-dispensed bottles, which were filled at the pharmacy and do not contain lot numbers, should contact the pharmacy where they purchased the medicine to determine if they are in possession of product that has been recalled.
The griseofulvin oral suspension may have a Patriot Pharmaceuticals, L.L.C., label. For more information you may call 1-800-426-7762 or 1- 800-510-0383.