Dey L.P., a subsidiary of Mylan Inc. (Nasdaq: MYL), today issued an advisory regarding two lots of its Albuterol Sulfate Inhalation Solution, 0.083%, unit-dose vials. The lots were on a tractor-trailer that was stolen in McKinney, Texas.
The product's NDC number is 49502-697-29; each carton displays the brand name "DEY" and contains thirty 3ml single-dose vials. The lot numbers are "9FE2" and "9G01." Neither lot was available commercially prior to the theft, and no vial or carton of either lot is part of the legitimate pharmaceutical supply chain. Dey has alerted its distributors and customers.
The products in the stolen cartons could represent a health risk because the required temperature-controlled supply chain may have been broken. Products from these lots should not be dispensed, sold or used.
Anyone who has information regarding this incident, has received suspicious or unsolicited offers for the Albuterol 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.