The Recall Desk

FDA (Drugs) recall action 75146

VIRTUS PHARMACEUTICALS OPCO II L recalled 3 products on 2016-12-28

The FDA (Drugs) publishes a recall like this one as 3 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 3 pages.

Products
3
Announced
2016-12-28
Critical
0
Units
129,659

Why these products were recalled

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

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

States named across these recalls

1–3 of 3

  • SevereFDA (Drugs)··2016-12-28

    Virtus Recalls Hyoscyamine Sulfate Tablets Due to Content Uniformity Failures

    Virtus Pharmaceuticals is recalling Hyoscyamine Sulfate tablets because they failed content uniformity specifications, resulting in both superpotent and subpotent doses.

    Product
    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.
    Category
    Distribution
    1 state
  • SevereFDA (Drugs)··2016-12-28

    Virtus Recalls Hyoscyamine Sulfate Tablets Due to Potency Failures

    Virtus Pharmaceuticals is recalling 24,444 bottles of Hyoscyamine Sulfate tablets because they failed content uniformity specifications, resulting in inconsistent drug potency.

    Product
    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.
    Category
    Distribution
    1 state
  • SevereFDA (Drugs)··2016-12-28

    Virtus Recalls Hyoscyamine Sulfate Tablets Due to Content Uniformity Failures

    Virtus Pharmaceuticals is recalling Hyoscyamine Sulfate sublingual tablets because they failed content uniformity specifications, resulting in tablets that are either superpotent or subpotent.

    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.
    Category
    Distribution
    1 state