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You are here: Home / Food Recalls / FDA Press Releases / FDA Warning: Do Not Use Stolen Albuterol Sulfate and Ipratropium Bromide Inhalation Solutions

FDA Warning: Do Not Use Stolen Albuterol Sulfate and Ipratropium Bromide Inhalation Solutions

September 18, 2009 By The FDA 1 Comment

The U.S. Food and Drug Administration advised 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

Do not use Albuterol Sulfate Inhalation Solution or Ipratropium Bromide Inhalation Solution if it is from one of these lots and was purchased or received after Sept. 8, 2009. Replace it with the same product from another lot.

Notify your health care professional of any adverse effects you may have experienced as a result of taking these medications.

Bring products from these lots back to the pharmacy where you received the medicine to exchange for products from a different lot or call Dey customer service at 800-527-4278. Contact your health care professional if you must switch to another product for any reason for possible dose adjustments.

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Filed Under: FDA Press Releases

About The FDA

The Food and Drug Administration (FDA) is an agency within the U.S. Department of Health and Human Services. It consists of the Office of the Commissioner and four directorates overseeing the core functions of the agency: Medical Products and Tobacco, Foods and Veterinary Medicine, Global Regulatory Operations and Policy, and Operations.

Comments

  1. kay says

    September 28, 2009 at 4:33 pm

    my mot;her received albuterol sulfate after September 8, DEY
    the NDC #4950269761 Lot# 9D59 she said it had a offensive taste to it, not what she was use to. I called the drugstore and they said the lot number was not on the list.

    Reply

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