Pre-Pen (benzylpenicilloyl polylysine) is once again being distributed by Hollister-Stier Laboratories LLC, Spokane.
The penicillin skin-test reagent was recalled by the Food and Drug Administration in 2001. Following several meetings between the contracted manufacturer, FDA, and Hollister-Stier, agreement to reinitiate production was reached in late 2001, the company said.
But the future availability of Pre-Pen is not absolutely certain. The Pre-Pen currently in production will be the final material produced by the contracted manufacturer, providing only a 3-year supply. Hollister-Stier said they have secured a new supplier and initiated plans to have the new source certified by the FDA before the existing 3-year supply is used up.
In a letter to physicians, Hollister-Stier asked physicians to help in ensuring that supplies remain available for the next 3 years by not purchasing large quantities in anticipation of product shortages. The company also said that the increased price for Pre-Pen . . . [Full Text of this Article]