RecallDepth
Class I Terminated

Hyoscyamine Sulfate, USP Tablets, 0.125 mg, 100-count tablets per bottle, Rx only, Manufactured for: Virtus Pharmaceuticals OPCO II, LLC., Nashville, TN 37217, NDC 76439-308-10.

Company
Virtus Pharmaceuticals Opco Ii L
Recall Initiated
September 2, 2016
Posted
December 28, 2016
Recall Number
D-0214-2017
Voluntary / Mandated
Voluntary: Firm initiated
Quantity
24,444 bottles
Firm Location
Nashville, TN, United States

Reason for Recall

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

Distribution

Nationwide and Puerto Rico

Lot / Code Info

Lot #: 30031601, 30031602, Exp 01/18

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