FDA Recall D-0214-2017
VIRTUS PHARMACEUTICALS OPCO II L · Nashville, TN
Class I — life-threatening Terminated 1116 days on record
Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.
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.
Reason for recall
Failed Content Uniformity Specifications: resulting in both superpotent and subpotent tablets.
Recall record
- Recall number
D-0214-2017- Classification
- Class I
- Status
- Terminated
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Distribution
- Nationwide and Puerto Rico
- Recall initiated
- 2016-09-02
- Classified by FDA Center
- 2016-12-22
- FDA published
- 2016-12-28
- Terminated
- 2019-09-23
- Recalling firm
- VIRTUS PHARMACEUTICALS OPCO II L
- Firm location
- Nashville, TN