Safety Alerts & Recalls

What does this mean?

Because the stolen product may have been stored or handled improperly and can affect how well ipratropium solution works, this alert should be taken seriously. If you are using a nebulizer solution of ipratropium in 2.5 mL unit-dose vials, please monitor your prescription refills to see if your supply is from one of the following lots: F09089, C09119, or C09120. You can locate the lot number on the side of the box of ipratropium or on the unit-dose vials. Do not use your ipratropium 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 Ipratropium Bromide Inhalation Solution, 0.02%, 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 Ipratropium, please follow up with you doctor as soon as possible.

Three Lots of Ipratropium Bromide Inhalation Solution, 0.02% Reported Stolen

Dey L.P., a subsidiary of Mylan Inc., has reported the theft of three lots of their product Ipratropium Bromide Inhalation Solution, 0.02%, unit-dose vials for nebulization. The lots were on a tractor-trailer that was stolen in the state of Florida. In the weeks before the truck theft, some portion of each lot 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 2.5 ml vials and display the brand name "DEY." The stolen lot numbers and NDC numbers are: Lot number F09089 - NDC 49502-685-3

Lot numbers C09119 and C09120 - NDC 49502-685-62

Ipratropium solution (also sold under the name Atrovent) is given as a nebulizer treatment to treat bronchospasm related to chronic obstructive pulmonary disease, emphysema, and chronic bronchitis. This theft did not involve other brands of ipratropium solution or the inhaler form of ipratropium (also sold under the name Atrovent, Atrovent HFA).

For more information, please visit: more information here

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

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