In another case of stolen medication, the U.S. Food and Drug Administration (FDA) has issued a warning to consumers not to use stolen Albuterol Sulfate Inhalation Solution and Ipratropium Bromide Inhalation Solution.
The involved respiratory medications were purchased after September 8, 2009 and were manufactured by Dey L.P., a subsidiary of Mylan Inc. 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, said the agency. 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 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
The FDA is warning consumers 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, to replace the medication with the same product from another lot, and to notify your health care professional of any adverse effects you may have experienced as a result of taking these medications. The FDA also advises that products from these lots be returned to the pharmacy from where the medication was received to receive an exchange for products from a different lot, or to call Dey customer service, toll-free at 1-800-527-4278. Contact your health care professional if you must switch to another product for any reason for possible dose adjustments.
The FDA is also 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, toll-free, 1-800-551-3989 or visiting the OCI Web site at: http://www.fda.gov/OCI.
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