October 25, 2019
Citing superpotency concerns, Aurobindo Pharma USA Inc. is recalling more than 11,000 bottles of dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate, and amphetamine sulfate tablets (mixed salts of a single-entity amphetamine product), according to the October 23, 2019, US Food and Drug Administration (FDA) Enforcement Report.
The recall affects 20-mg tablets packaged in 100-count bottles (NDC 13107-073-01) from batch 07319032A1 (Exp. 2/21). The product was distributed throughout the United States.
Aurobindo Pharma USA initiated the recall September 19, 2019. On October 15, 2019, the FDA designated the recall Class II. Drugs affected by Class II recalls may cause temporary or medically reversible adverse health consequences if used. While remote, a possibility of serious harm also exists.
Dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate, and amphetamine sulfate is a single-entity amphetamine product available with a prescription for the treatment of attention-deficit/hyperactivity disorder (ADHD) and narcolepsy.