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.
Reported: December 28, 2016 Initiated: September 2, 2016 #D-0212-2017
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.
Details
- Recalling Firm
- VIRTUS PHARMACEUTICALS OPCO II L
- Units Affected
- 94,643 bottles
- Distribution
- Nationwide and Puerto Rico
- Location
- Nashville, TN
Frequently Asked Questions
What product 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.. Recalled by VIRTUS PHARMACEUTICALS OPCO II L. Units affected: 94,643 bottles.
Why was this product recalled? ▼
Failed Content Uniformity Specifications: resulting in both superpotent and subpotent tablets.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on December 28, 2016. Severity: Critical. Recall number: D-0212-2017.
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