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FDA Medwatch Alert: Hyoscyamine sulfate 0.125mg by Virtus Pharmaceuticals: Recall - Superpotent and Subpotent Test Results

Posted 16 Sep 2016 by Drugs.com

ISSUE: Virtus Pharmaceuticals Opco II, LLC (Virtus) is voluntarily recalling seven batches of Hyoscyamine sulfate (0.125mg) to the consumer level which include the tablet, sublingual, and orally disintegrating tablet form. This recall is being initiated due to both superpotent and subpotent test results. All of these batches were manufactured by Pharmatech LLC for distribution by Virtus throughout the United States and Puerto Rico. See the press release for a listing of affected batch numbers. Taking a product that is superpotent could result in hot/dry skin, fever, blurred vision, sensitivity to light, dry mouth, unusual excitement, fast or irregular heartbeat, dizziness, an inability to completely empty the bladder, and seizures. The severity of the adverse event would depend on how superpotent the tablet was. Adverse events such as clotted blood within the tissues and fractures could ... Read more

Related support groups: Irritable Bowel Syndrome, Urinary Incontinence, Hyoscyamine, Levsin, Symax Duotab, Levsin SL, Hyosyne, Symax SL, Levbid, HyoMax, Symax FasTab, HyoMax SL, NuLev, Symax FasTabs, HyoMax SR, Levsinex SR, Levsinex, Hyosol, Anaspaz, Symax SR

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Irritable Bowel Syndrome, Anesthesia, Crohn's Disease, Urinary Incontinence, Endoscopy or Radiology Premedication

HyoMax DT Patient Information at Drugs.com