The US Food and Drug Administration (FDA) is advising consumers not to use certain respiratory medications purchased after September 8, 2009, and manufactured by Dey LP, a subsidiary of Mylan Inc. The advisory follows the theft of a shipment of medications from Dey LP stolen while being transported on a tractor-trailer in Tampa, Fla on September 8, 2009.
The stolen 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, according to the FDA’s advisory.
Although 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 September 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”)
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 (432,000 doses; all lots contain 2.5 ml vials and display the brand name “Dey”)
Lot number F09089, NDC # 49502-685-31
Lot number C09119, NDC # 49502-685-62
Lot number C09120, NDC # 49502-685-62
Consumers are advised to:
– Not use the medication if it is from one of the lots listed and was purchased or received after September 8, 2009. Consumers should replace it with the same product from another lot.
– Notify their health care professional of any adverse effects that might have been experienced as a result of taking these medications.
– Bring products from these lots back to the pharmacy where they were received to exchange for products from a different lot or call Dey customer service at (800) 527-4278.
– Contact their health care professional if they must switch to another product for any reason for possible dose adjustments.
– Report any information regarding the stolen Dey products to FDA’s Office of Criminal Investigations (OCI) by calling (800) 551-3989 or by visiting the OCI Web site.