Sunday, September 13, 2009

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)


Lot Expiration Date

June 2011

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.

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