BETHESDA, MD 14 August 2009—Barr Laboratories has recalled a single lot of a mixed-amphetamine product because some tablets may contain more drug than specified.
The recall involves lot 311756 of dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfate, or mixed salts of a single-entity amphetamine product. The recalled lot is formulated as 20-mg tablets packaged in bottles of 100 each and was distributed between June 11 and 16 of this year.
Barr`s product is a version of the attention deficit/hyperactivity medication commonly known as Adderall.
According to FDA`s reposting of Barr`s recall notice, dated August 13, some tablets in this lot may be oversized and superpotent.
Patients who are exposed to an excessive dose of amphetamine-containing products can suffer a variety of cardiovascular, neurologic, or gastrointestinal adverse events. The company stated that it has received no reports of adverse events associated with the oversized tablets.
The notice urges customers who have purchased the affected lot to stop using it and return the tablets to their pharmacy or distributor. Questions about the recall should be directed to the company at 888-742-5578 between 8 a.m. and 8 p.m Eastern Daylight Time Monday through Friday.
