Safety Alerts & Recalls

What does this mean?

Because the stolen product may have been stored or handled improperly and can affect how well albuterol solution works, this alert should be taken seriously. If you are using a nebulizer solution of albuterol in 3 ml unit-dose vials, please monitor your prescription refills to see if your supply is from one of the following lots: 9G04, FD8, 9FD9, 9FE1, 9FE2 and 9G01. You can locate the lot number on the side of the box of albuterol or on the unit-dose vials. Do not use your albuterol solution if it is from one of these lots.

Anyone who has information regarding this incident, or has received product from these lots is encouraged to contact the U.S. Food and Drug Administration (FDA) Office of Criminal Investigations at 1-800-551-3989. For more information about these stolen Albuterol Sulfate Inhalation Solution, 0.083%, unit-dose vials you can also contact the Dey Customer Service at 1-800-527-4278.

If you think you are experiencing side effects related to your Albuterol, please follow up with you doctor as soon as possible.

Several Lots of Albuterol Sulfate Inhalation Solution, 0.083% Reported Stolen

Dey L.P., a subsidiary of Mylan Inc., has reported the theft of several lots of their product Albuterol Sulfate Inhalation Solution, 0.083%, unit-dose vials for nebulization. Two separate tractor-trailers containing the product were stolen, one stolen in the state of Florida and one stolen in McKinney, Texas. Prior to the truck theft in Florida, some portion of the product had been legally sold by Dey to its customers and may currently be available in pharmacies. Since it is difficult to determine legal versus stolen product, any and all product with the affected lot numbers should not be used.

All packages involved in this theft alert contain 3 ml unit-dose vials and display the brand name "DEY." The stolen lot numbers and NDC numbers are: Lot number 9G04 - NDC 49502-697-29

Lot numbers FD8, 9FD9 and 9FE1 - NDC 49502-697-61

Lot numbers 9FE2 and 9G01 - NDC 49502-697-29

Albuterol solution (also sold under the name Accuneb) is given as a nebulizer treatment to treat asthma and chronic obstructive pulmonary disease (COPD). This theft did not involve other brands of albuterol solution or the other forms of albuterol (also sold under the name Proair HFA, Proventil HFA, Ventolin HFA, and Vospire ER).

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Source: Manufacturer
Publication Date: 2009-09-17
Last Updated: 2009-12-05

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