Virtus Recalls Hyoscyamine Sulfate

September 15, 2016
Pharmaceutical Technology Editors

Virtus Pharmaceuticals Opco II, LLC is voluntarily recalling batches of hyoscyamine sulfate (0.125mg).

On Sept. 14, 2016, Virtus Pharmaceuticals Opco II, LLC announced the voluntary recall of seven batches of hyoscyamine sulfate (0.125mg) due to both superpotent and subpotent test results. The batches, which were distributed by Virtus in the United States and Puerto Rico from March 11, 2016, were manufactured by Pharmatech LLC. The recall was in response to adverse events reported in relation to the recalled product.

Virtus stated in a press release that a superpotent product “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.” Three adverse events have been reported that include temporary hallucinations, stroke-like symptoms, confusion, dizziness, blurred vision, dry mouth, slurred speech, imbalance, and disorientation. 

According to Virtus, hyoscyamine sulfate is an anticholinergic agent that blocks the action of acetylcholine. It is used to treat asthma, incontinence, stomach cramps, peptic ulcers, control gastric secretion, and intestinal spasm. 

Information about the recalled product can be found on FDA’s website and adverse events can be reported to the agency’s Med Watch page

Source: FDA