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Hyoscyamine Tablets Recalled Because of Potency Concerns

September 17, 2016 | 2 min read

The United States Food and Drug Administration (“FDA”) has issued an announcement stating that Virtus Pharmaceuticals Opco II, LLC (“Virtus”) is voluntarily recalling seven batches of Hyoscyamine sulfate manufactured by Pharmatech LLC.  This recall was initiated because test results indicated that certain batches of the drug were either superpotent or subpotent.  In other words, certain batches of the drug are stronger (superpotent) or weaker (subpotent) than they should be.  A list of the batches recalled can be found here.[1]

Hyoscyamine sulfate is used to treat conditions such as asthma, incontinence, stomach cramps, peptic ulcers, and other bowel disturbances.  The specific products recalled were distributed in both the United States and Puerto Rico starting on March 11, 2016.

Virtus has received reports indicating that this drug has potentially caused users to suffer hallucinations, stroke-like symptoms, confusion, dizziness, blurred vision, dry mouth, slurred speech, imbalance, and disorientation.  Further, the FDA has warned that taking a superpotent dose of this drug could result in a variety of symptoms, including fever, unusual excitement, sensitivity to light, and fast or irregular heartbeats.  Individuals who fall because of any dizziness or seizures caused by this drug may be at risk for developing blood clots within injured tissues or bones.

If you or a loved one suffered injuries that you believe were caused by Hyoscyamine sulfate manufactured by Pharmatech LLC, contact one of the experienced medical drug attorneys at Burg Simpson today.  Our award-winning lawyers would be happy to discuss your potential claim.  Call 1-800-713-9340 or fill out our contact form for a FREE no-obligation consultation today.

[1] Virtus Pharmaceuticals Opco II, LLC Issues Voluntary Nationwide Recall of Hyoscyamine sulfate Due to Superpotent and Subpotent Results