Drug Safety Alerts

Hyoscyamine Sulfate 0.125 mg Tablets Consumer-Level Recall

09/15/2016

On September 15, 2016, the United States Food and Drug Administration (FDA) issued a notice regarding a consumer-level recall of hyoscyamine sulfate 0.125 mg tablets manufactured by Pharmactech and distributed by Virtus Pharmaceuticals. This recall was issued 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.

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 are all believed to be temporary. None of the adverse events were life threatening, and the patients who reported the incidents were treated and released.

These products were distributed Nationwide in the U.S. and Puerto Rico starting on March 11, 2016, to distributors, hospitals, and retail pharmacies.

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.

CVS Caremark Response: Because of this action, CVS Caremark is sending letters to members who received this product through CVS Caremark Mail Service Pharmacy and their physicians.

For more information, health care providers may contact Virtus at 1-855-255-6076, Monday through Friday, 8:00 am to 5:00 pm (ET) or visit http://www.virtusrx.com/press-release-hyoscyamine-sulfate-recall/.

You may also contact the FDA consumer inquiry line at 1‑888‑INFO-FDA (1‑888-463-6332) or visit http://www.fda.gov.