Virtus Pharmaceuticals Issues Recall of Hyoscyamine Sulfate Due to Superpotent, Subpotent Results

taking a product that is superpotent could result in serious adverse reactions

Virtus Pharmaceuticals Issues Recall of Hyoscyamine Sulfate Due to Superpotent, Subpotent Results
Image: Pixabay
September 15, 2016

Virtus Pharmaceuticals Opco II is voluntarily recalling seven batches of Hyoscyamine sulfate (0.125mg) to the consumer level which include the tablet, sublingual, and orally disintegrating tablet form.

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 occur, as a result of falls from dizziness or seizures if the strength is particularly high.

To date, Virtus has received three adverse event reports involving hallucinations, stroke-like symptoms, confusion, dizziness, blurred vision, dry mouth, slurred speech, imbalance, and disorientation. These symptoms were reported to be resolved and believed to be temporary.

None of the adverse events were life threatening, and the patients who reported the incidents were treated and released.

The following items are included in this recall:

  • Tablets have a NDC of 76439-308-10, batch number 30031601 and 30031602, an expiration date of Jan-18, and came in a 100 count.
  • Orally Disintegrating Tablets have a NDC of 76439-307-10, batch number 30011601, an expiration date of Jan-18, and came in a 100 count.
  • Sublingual Tablets have a NDC of 76439-309-10, batch number 30051601, 30051602, 30051603, and 30051604, expiration dates of Jan-18 and Jan-28, and came in a 100 count.

Virtus is notifying its distributors and retailers by letter and email and is arranging for return of all recalled drug product. Consumers, distributors, and retailers that have the hyoscyamine sulfate product lots listed above should stop using/distributing and return to place of purchase.

For more information, consumers can contact Virtus at (855) 255-6076.