VIRTUS PHARMACEUTICALS OPCO II L recalls Hyoscyamine Sulfate, Sublingual Tablets, 0.125 mg, 100-count bottle, Rx only, Manufactured for: Virtus Pharmaceuticals…
- Recall date
- September 2, 2016
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- D-0212-2017
- FDA classification
- Class I
- Brand / firm
- VIRTUS PHARMACEUTICALS OPCO II L
- Sold / distributed
- Nationwide and Puerto Rico
Why it was recalled
Failed Content Uniformity Specifications: resulting in both superpotent and subpotent tablets.
Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.
What was recalled
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.
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