Earlier this month Bedford Laboratories updated guidance on its August 2011 recall of Polymyxin B for Injection USP and Vecuronium Bromide for Injection. Since there have been a number of recalls throughout the industry involving glass vials, we posed a few questions regarding the updated guidance. (Note: Bedford Laboratories is a division of Ben Venue Laboratories, of the Boehringer Ingelheim group of companies.)
Jason Kurtz, Associate Director, Communications & Public Relations, explained that “For background, Ben Venue manufactures sterile injectable products which must be packaged in glass vials. This recall was caused by an issue on a manufacturing line that caused glass breakage during processing which has since been corrected.”
The company is “working closely with our distributors to ensure the return of the affected lots. To date, there have been no reports of adverse events related to the products involved in this recall,” Kurtz reports.
We asked about Ben Venue Laboratories’ position related to item-level serial numbers on all drug packages. “BVL supports any initiatives that might help minimize supply disruptions or potential shortages,” he said.
The recalls were initiated on August 2, 2011 after the discovery of a visible glass particle in a limited number of vials within the lots listed above to the user level.