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Medication Safety Alerts

Hyoscyamine Sulfate 0.125 mg Tablets Voluntary Recall

09/15/2016

On September 15, 2016, the United States Food and Drug Administration (FDA) issued a notice regarding a voluntary recall of hyoscyamine sulfate 0.125 mg tablets manufactured by Pharmactech and distributed by Virtus Pharmaceuticals. This recall was issued because the tablets could be too strong (superpotent) or not strong enough (subpotent).

This may represent a potential health hazard or safety risk to plan members who may be using product affected by this recall.

This recall affects the following products:

  • Hyoscyamine Sulfate 0.125 mg Sublingual Tablets
  • Hyoscyamine Sulfate 0.125 mg Oral Disintegrating Tablets
  • Hyoscyamine Sulfate 0.125 mg Tablets

Product affected by this recall was distributed between March 11, 2016 and September 15, 2016. If you did not receive product during this time, it is not affected by this recall. If you did receive product during this time, please contact the pharmacy that filled your prescription for further instructions.

You should not continue to use product that is affected by this recall. Please call your doctor right away for advice if you may be using affected product or if you do not know if you used affected product or not. Your doctor is familiar with your medical history and can suggest the best treatment option for you. If you need a prescription for a different medicine, please call your doctor.

CVS Caremark Response: If you are currently taking hyoscyamine sulfate 0.125 mg tablets manufactured by Virtus Pharmaceuticals, please call a Customer Care representative toll-free at 1‑866‑823‑5184. We will give you more information and help with arrangements for the return and replacement of any affected product.

If you are currently taking hyoscyamine sulfate 0.125 mg tablets manufactured by Virtus Pharmaceuticals, and have questions regarding this recall, please call your doctor or call Virtus toll-free 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 call the U.S. Food and Drug Administration (FDA) consumer inquiry line toll-free at 1‑888‑INFO‑FDA (1‑888‑463‑6332) or visit http://www.fda.gov/.

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