Anticholinergic Agent Used for GI, Other Disorders Recalled

Virtus announced a voluntary recall of 7 lots of Hyoscyamine Sulfate 0.125mg due to both superpotent and subpotent test results.

Hyoscyamine sulfate is an anticholinergic agent used as adjunctive therapy in the treatment of peptic ulcer. It can also be used to control gastric secretions, visceral spasm and hypermotility in spastic colitis, spastic bladder, cystitis, pylorospasm and associated abdominal cramps. It may be used in functional intestinal disorders to reduce symptoms such as those seen in mild dysenteries, diverticulitis and acute enterocolitis, as an adjunct in the treatment of irritable bowel syndrome (irritable colon, spastic colon, mucous colitis) and functional gastrointestinal disorders, and in the treatment of neurogenic bladder and neurogenic bowel disturbances (including the splenic flexure syndrome and neurogenic colon). 

Other uses include symptomatic relief of biliary and renal colic; as a “drying agent” in the relief of symptoms of acute rhinitis; in the therapy of parkinsonism to reduce rigidity and tremors and to control associated sialorrhea and hyperhidrosis; and as therapy for poisoning by anticholinesterase agents.

The affected lots include the tablet, sublingual tablet, and orally-disintegrating tablet formulations of Hyoscyamine Sulfate. The affected products were manufactured by PharmaTech and were distributed starting on March 11, 2016. They include the following formulations:

Sublingual Tablets 0.125mg (100-count):

• Lot #30051601, Exp date 1/18
• Lot #30051602, Exp date 1/18 (may be incorrectly dated as 1/28)
• Lot #30051603, Exp date 1/18
• Lot #30051604, Exp date 1/18

Orally Disintegrating Tablets 0.125mg (100-count):

• Lot #30011601, Exp date 1/18

Tablets 0.125mg (100-count):

• Lot #30031601, Exp date 1/18
• Lot #30031602, Exp date 1/18

Taking a superpotent drug product can yield potentially serious adverse events such as hot/dry skin, fever, blurred vision, light sensitivity, dry mouth, unusual excitement, fast or irregular heartbeat, dizziness, inability to completely empty the bladder, and seizures. Based on the superpotency of the tablet, other adverse events such as fractures due to falls from dizziness or seizures could occur. 

Virtus has received three adverse event reports including hallucinations, stroke-like symptoms, confusion, dizziness, blurred vision, dry mouth, slurred speech, imbalance, and disorientation. 

Consumers, distributors, and retailers that have the Hyoscyamine Sulfate product lots listed above should stop using or distributing this product and return it to the place of purchase.

For more information call (855) 255-6076 or visit VirtusRX.com.