FDAFDA · Food and drugs·Recall number D-0212-2017
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.
Published December 28, 2016 · Recall initiated: September 2, 2016
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Failed Content Uniformity Specifications: resulting in both superpotent and subpotent tablets.
What to do
Voluntary: Firm initiated · E-Mail
Recall details
- Manufacturer
- VIRTUS PHARMACEUTICALS OPCO II L
- Distributor
- Nationwide and Puerto Rico
- Lot
- Lot #: 30051601, 30051602*, 30051603, 30051604, Exp Jan-18, *some bottles contain the incorrect expiration date of Jan-28.
- Risk classification
- Class I
- Area (FDA)
- drug
- Country
- United States
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