FDA Warns About Stolen Lots of Albuterol Sulfate Inhalation Solution

More than 35,000 cartons of Albuterol Sulfate Inhalation Solution recently stolen from a tractor-trailer container may have been altered and can pose a risk of serious injury to users, the Food and Drug Administration is warning.

The product, made by Dey, L.P., is used by asthmatics to prevent and treat respiratory difficulties associated with the chronic respiratory condition.

Two lots containing 0.083% unit-dose vials of the drug were reported stolen along with a tractor-trailer on or about August 6 in McKinney, Texas, the FDA said. The stolen lots – 9FE2 and 9GO1 – carry expiration dates of June 2011 or July 2001.

The drugs in the two lots reported stolen were not available to the public before they were taken, so all cartons of the products from the lots are suspected of being potentially dangerous. The products may have been altered or improperly stored, making them potentially dangerous to patients who use them.

The FDA and Dey are advising pharmacists to closely examine all supplies of Albuterol Sulfate Inhalation Solution to determine whether any are from the pirated lots. No products from the stolen lots should be sold or otherwise distributed to patients, the FDA said.

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