December 20, 2019
A foreign object found in a tablet has prompted Jubilant Cadista Pharmaceuticals Inc. to recall a single lot of amantadine hydrochloride tablets, 100 mg, according to the December 18, 2019, US Food and Drug Administration (FDA) Enforcement Report.
The recall spans 1824 bottles of 100-count amantadine hydrochloride tablets (NDC 59746-699-01) from lot NT119005A (Exp. 7/21). The recalled product was distributed throughout the United States.
Jubilant Cadista Pharmaceuticals initiated the voluntary recall December 2, 2019. The FDA designated the recall Class II on December 6, 2019. 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.
Amantadine hydrochloride is a prescription antiviral and dopamine promoter used to treat the flu as well as Parkinson disease and similar conditions.