FDA is alerting you to a pharmaceutical theft of Albuterol Sulfate Inhalation Solution, 0.083%, unit-dose vials and Ipratropium Bromide Inhalation Solution, 0.02%, manufactured by DEY L.P., a subsidiary of Mylan Inc.  The drugs were on a tractor-trailer that was stolen on September 8, 2009, in the state of Florida.

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 product with the affected lot numbers be isolated and not be dispensed, sold or used. Dey has alerted its distributors and customers.
 

The FDA and the Partnership for Safe Medicines are committed to protecting the public from receiving stolen drug products that may not have been stored and handled properly and may be dangerous for patients to use. 
 
If you receive any suspicious or unsolicited offers for these stolen drug products after the date of the theft 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/OCI).  Patient or customer inquiries for the company should be directed to Dey Customer Service at 1.800.527.4278.

 

We would also like to remind you of the SafeMeds Alerts that we shared with you last month about additional lots of Dey Albuterol Sulfate Inhalation Solution, 0.083% unit dose vials (lot numbers 9FE2 and 9G01) that were stolen on August 6, 2009, and Advair Diskus(R) - Fluticasone Propionate and Salmeterol Inhalation Powder (lot numbers 9ZP2255 and 9ZP3325) that was stolen on August 2, 2009 from the manufacturer's distribution facility in Virginia.  Please also check your stock for these lots and remove them from distribution as well.
 

Sept. 17, 2009

 

The U.S. Food and Drug Administration today advised consumers not to use certain respiratory medications purchased after Sept. 8, 2009 and manufactured by Dey L.P., a subsidiary of Mylan Inc., because the medications might have been part of a shipment being transported on a tractor-trailer stolen in Tampa, Fla., on Sept. 8, 2009.

The respiratory medications, Ipratropium Bromide Inhalation Solution, 0.02%, and Albuterol Sulfate Inhalation Solution, 0.083%, unit-dose vials, have not been recovered and may be dangerous to use because the drugs may not have been stored and handled properly.

Dey issued an advisory on Sept. 11, 2009 regarding the theft. Although the FDA is not aware of any reports of adverse events, the agency is advising patients who use these respiratory medications to check to see if products received or purchased after Sept. 8, 2009 are from one of the following lots:

Albuterol Sulfate Inhalation Solution (892,000 doses; all lots contain 3.0 ml vials and display the brand name "Dey")

 

Ipratropium Bromide Inhalation Solution (432,000 doses; all lots contain 2.5 ml vials and display the brand name "Dey")

 

Do not use Albuterol Sulfate Inhalation Solution or Ipratropium Bromide Inhalation Solution if it is from one of these lots and was purchased or received after Sept. 8, 2009. Replace it with the same product from another lot.

 

Notify your health care professional of any adverse effects you may have experienced as a result of taking these medications.

Bring products from these lots back to the pharmacy where you received the medicine to exchange for products from a different lot or call Dey customer service at 800-527-4278. Contact your health care professional if you must switch to another product for any reason for possible dose adjustments.

The FDA is asking for the public's help in reporting any information regarding the stolen Dey products to the FDA's Office of Criminal Investigations (OCI) by calling 800-551-3989 or by visiting the OCI Web site (http://www.fda.gov/OCI).