Voluntary Product Withdrawal Announcement
NAPA, Calif.--Sept. 11, 2009--Dey L.P., a subsidiary of Mylan (NASDAQ: MYL), today issued an advisory regarding the theft of two different types of its respiratory medications, Ipratropium Bromide Inhalation Solution, 0.02%, and Albuterol Sulfate Inhalation Solution, 0.083%, unit-dose vials. The lots were on a tractor-trailer that was stolen in the state of Florida.
The NDC numbers for the Ipratropium product are 49502-685-31 (lot number F09089) and 49502-685-62 (lot numbers C09119 and C09120). All packages contain 2.5 ml vials and display the brand name "Dey."
The NDC numbers for the Albuterol product are 49502-697-29 (lot number 9G04) and 49502-697-61 (lot numbers 9FD8, 9FD9 and 9FE1). All packages contain 3.0 ml vials and display the brand name "Dey."
In the weeks prior to the truck theft, some portion of each lot had been sold by Dey to its customers and successfully entered the legitimate pharmaceutical supply chain. Because the stolen product may have been stored or handled improperly, Dey is requesting that any and all product with the affected lot numbers be isolated and not be dispensed, sold or used. Dey has alerted its distributors and customers.
Anyone who has information about this incident, has received suspicious or unsolicited offers for the products in question or received product from these lots is encouraged to contact the U.S. Food and Drug Administration (FDA) Office of Criminal Investigations at 1.800.551.3989. Patient or customer inquiries for the company should be directed to Dey Customer Service at 1.800.527.4278.
Dey discourages patients from purchasing any medication sold outside of legitimate channels.
Dey L.P., a subsidiary of Mylan (NASDAQ: MYL), is a specialty pharmaceutical company focused on the development, manufacturing and marketing of prescription drug products for the treatment of respiratory diseases, respiratory-related allergies and emergency care medicine. As the U.S. leader in sales of nebulized respiratory medication, Dey puts patients first through its development of innovative and affordable therapies.
Michael Laffin (Media)
Dan Crookshank (Investors)