Product: Hyoscyamine Sulfate, Sublingual Tablets, 0.125 mg, 100-count bottle, Rx only, Manufactured for: Virtus Pharmaceuticals OPCO II, LLC., Nashville, TN 37217, NDC 76439-309-10.
Reason for recall: Failed Content Uniformity Specifications: resulting in both superpotent and subpotent tablets.
Recall initiated: 20160902
Status: Terminated
Classification: Class I
Recall type: Voluntary: Firm initiated