FDA Warns About Stolen Respiratory Meds

The FDA is advising consumers not to use certain respiratory medications purchased after September 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, Florida, on that date.
The respiratory medications, ipratropium bromide inhalation solution 0.02% and albuterol sulfate inhalation solution 0.083%, 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 September 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 if products they received or purchased after September 8, 2009, are from one of the following lots:

• Albuterol sulfate inhalation solution
• • Lot number 9G04, NDC #49502-697-29
  • Lot number 9FD8, NDC #49502-697-61
  • Lot number 9FD9, NDC #49502-697-61
  • Lot number 9FE1, NDC #49502-697-61
• Ipratropium bromide inhalation solution
• • Lot number F09089, NDC #49502-685-31
  • Lot number C09119, NDC #49502-685-62
  • Lot number C09120, NDC #49502-685-62

Patients should not use these medications if they are from one of these lots and were purchased or received after September 8, 2009. Instead, patients should replace their medication with the same product from another lot.

Consumers should notify their health care professional of any adverse effects they may have experienced as a result of taking these medications.

If patient do have any of the affected medications, they should bring the products back to the pharmacy where they received the medicine to exchange for products from a different lot. Patients can also call Dey customer service at 800-527-4278.

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 by calling 800-551-3989 or by visiting the OCI Web site at www.fda.gov/OCI.

Contact:
Christopher Kelly
301-796-4676
Christopher.Kelly@fda.hhs.gov