VIRTUS PHARMACEUTICALS OPCO II L recalls Hyoscyamine Sulfate, Sublingual Tablets, 0.125 mg, 100-count bottle, Rx only, Manufactured for: Virtus Pharmaceuticals O
Recalled December 28, 2016 · FDA recall D-0212-2017 · VIRTUS PHARMACEUTICALS OPCO II L
Hazard
Failed Content Uniformity Specifications: resulting in both superpotent and subpotent tablets. · FDA Class I
Units
94,643 bottles
Sold at
Nationwide and Puerto Rico
Description
Failed Content Uniformity Specifications: resulting in both superpotent and subpotent tablets.
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.
Manufacturer(s)
VIRTUS PHARMACEUTICALS OPCO II L
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →