D-0212-2017 Class I Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- December 28, 2016
- Initiation Date
- September 2, 2016
- Termination Date
- September 23, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 94,643 bottles
Product Description
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.
Reason for Recall
Failed Content Uniformity Specifications: resulting in both superpotent and subpotent tablets.
Distribution Pattern
Nationwide and Puerto Rico
Code Information
Lot #: 30051601, 30051602*, 30051603, 30051604, Exp Jan-18, *some bottles contain the incorrect expiration date of Jan-28.