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Parkinson Drug Recalled
Aurobindo Pharma USA Inc. is recalling 9890 bottles of rasagiline tablets because samples failed to meet dissolution specifications during testing, according to the September 20, 2023, US Food and Drug Administration (FDA) Enforcement Report.
The recall affects rasagiline tablets 0.5 mg, 30-count bottles (NDC 0378-1270-93), from lot 3112444 (Exp. 8/23). The product was distributed throughout the United States.
Aurobindo Pharma USA voluntarily initiated the recall August 2, 2023. The FDA designated the recall Class II on September 18, 2023. 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.
Rasagiline is a prescription drug indicated for the treatment of Parkinson disease.