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Vertigo Drug Recalled
Rising Pharmaceuticals is recalling a single lot of meclizine hydrochloride tablets because of incorrect instructions on product labeling, according to the October 13, 2021, US Food and Drug Administration (FDA) Enforcement Report.
The recall affects 25-mg meclizine hydrochloride tablets in 100-count bottles (NDC 16571-752-01) from lot CB21024 (Exp. 2/23). The product was manufactured by Aurex Laboratories and distributed by Rising Pharma Holdings Inc, East Brunswick, NJ. At press time, the FDA had not specified where the tablets were distributed.
Rising Pharmaceuticals voluntarily initiated the recall September 2, 2021. The FDA designated the recall Class II on October 7, 2021. 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.
Meclizine hydrochloride is a prescription medication used to treat vertigo associated with conditions affecting the vestibular system in adults.