Hyoscyamine Sulfate, Orally Disintegrating Tablets, 0.125 mg, 100-count bottles, Rx only, Manufactured for: Virtus Pharmaceuticals OPCO II, LLC., Nashville, TN 37217, NDC 76439-307-10.

Recall Number: D-0213-2017

Firm: VIRTUS PHARMACEUTICALS OPCO II L

Classification: Class I

Status: Terminated

Report Date: 20161228

Initiation Date: 20160902

Termination Date: 20190923

Failed Content Uniformity Specifications: resulting in both superpotent and subpotent tablets.

Hyoscyamine Sulfate, Orally Disintegrating Tablets, 0.125 mg, 100-count bottles, Rx only, Manufactured for: Virtus Pharmaceuticals OPCO II, LLC., Nashville, TN 37217, NDC 76439-307-10.