FDA Issues Warning about Stolen Albuterol Sulfate and Ipratropium Bromide Inhalation Solutions

The U.S. Food and Drug Administration (FDA) is advising 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")

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

SEPT-18-09: FDA Issues Warning about Stolen Albuterol Sulfate Inhalation Solution and Ipratropium Bromide Inhalation Solution [FDA: WARNS ABOUT STOLEN ALBUTEROL AND IPRATROPIUM INHALATION SOLUTIONS]

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Published on Sep-18-09