Dey Labs: Update on Stolen Albuterol Sulfate Inhalation Solution

As posted on the FDA Website and as a service to those interested in combating fraudulent, adulterated and counterfeit medications, the following is an announcement from Dey Labs:

In keeping with its commitment to “Put Patients First,” Dey, L.P. (“Dey’) would like to take this opportunity to inform its healthcare partners regarding a recent occurrence of stolen medication.

On or about August 6, 2009, a truck tractor-trailer which was not affiliated with Dey, containing 35,760 cartons of Albuterol Sulfate Inhalation Solution, 0.083%, unit-dose vials was stolen. The truck theft occurred in the town of McKinney Texas.

The tractor-trailer contained two (2) complete Lots of product, each identified with the Dey label and NDC number. The specific product information is as follows:

Product Description:Albuterol Sulfate Inhalation Solution 0.083% 30-vials per carton (Product NDC #49502-697-29)

OT #	CARTON QUANTITY				Lot Expiration Date
9FE2	17,712				June 2011
9G01	18,048				July 2011

These two Lot numbers were not available commercially prior to the theft. All of the product cartons in these two Lots were stolen. Therefore, no vial or carton of either Lot is part of the legitimate pharmaceutical supply chain.

Pharmacies are encouraged to verify pedigree documentation for all purchases of Dey labeled Albuterol Sulfate, 0.083%, 30-vial cartons and product with either of these two Lots numbers should not be sold, distributed or dispensed.

If you have any information regarding the theft of these two Lots, or if you receive any suspicious or unsolicited offers for the Albuterol in question, please contact the Food and Drug Administration (“FDA”) Office of Criminal Investigations (“OCI”) by calling 1-800-551-3989.

For Customer Service inquiries, contact Dey, L.P. Customer Service at 1-800-527-4278.

For medical or other clinically related inquiries about this matter, contact Dey’s Senior Vice President of Quality Systems at 1-800-755-5560, ext. 2476.

SafeMeds Alert: FDA Warns Healthcare Professionals and Public About Stolen Asthma Drug

Nearly 36,000 Cartons of Dey Brand Generic Albuterol Sulfate Inhalation Solution Stolen in Texas

SafeMed via their on-line and email alert system is sending out information on the FDA alert to patients and healthcare professionals regarding a cargo theft of 35,760 cartons of Dey brand generic Albuterol Sulfate Inhalation Solution that occurred on approximately August 5, 2009.

On August 7, 2009, it was reported that in McKinney, Texas, a tractor-trailer containing a 35,760-carton shipment of an asthma drug belonging to the RiteDose Corporation was stolen. The product in question is Albuterol Sulfate Inhalation Solution 0.083%. The NDC number is 49502-697-29. Each carton displays the brand name "DEY" and contains thirty 3ml single-dose vials. The lot numbers of the stolen product were "9G01" and "9FE2." These two lot numbers were not commercialized prior to the theft. All the product units in these lots were stolen. The product could represent a health risk because the required temperature-controlled supply chain may have been broken.

If you receive any offers for these stolen drug products or think that you may have been sold the stolen drug products referenced in this notice, FDA is asking your help in reporting this information to FDA's Office of Criminal Investigations (OCI) by calling 800-551-3989 or by visiting the OCI Web site, http://www.fda.gov/ICECI/CriminalInvestigations/ucm123025.htm.

To learn more about SafeMed Alerts, go online at www.safemeds.org.