The US Food and Drug Administration advised consumers not to use certain respiratory medications purchased after September 8, 2009 and manufactured by Dey LP, 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 September 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 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 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). Lot numbers are 9G04, NDC # 49502-697-29; 9FD8, NDC # 49502-697-61; 9FD9, NDC # 49502-697-61; and 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 numbers are F09089, NDC # 49502-685-31; C09119, NDC # 49502-685-62; and C09120, NDC # 49502-685-62.
US FDA has advised not to use Albuterol Sulfate Inhalation Solution or Ipratropium Bromide Inhalation Solution if it is from one of these lots and was purchased or received after September 8, 2009. Replace it with the same product from another lot.
Products from these lots should be submitted back to the pharmacy from it was received the medicine to exchange for products from a different lot or 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 (OCI) by calling 800-551-3989 or by visiting the OCI.