Johnson & Johnson said the voluntary recall is a precaution based on two reports of glass fragments found in bottles of the liquid formulation.
The voluntary recall is being conducted by Ortho Dermatological, a division of Ortho-McNeil Pharmaceutical and 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. Johnson & Johnson 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, and action is being taken to change the over-wrap to prevent this possible occurrence in the future. There have been no reports of adverse events from the reported glass fragments in broken bottles.
The lots were shipped to distributors in the US between August 23, 2005, and March 14, 2007.