Recalls / Class I
Class ID-0212-2017
Class I— FDA's most serious classification, issued when there is a reasonable probability that use of or exposure to the drug will cause serious adverse health consequences or death.
Product
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.
- Affected lot / code info
- Lot #: 30051601, 30051602*, 30051603, 30051604, Exp Jan-18, *some bottles contain the incorrect expiration date of Jan-28.
Why it was recalled
Failed Content Uniformity Specifications: resulting in both superpotent and subpotent tablets.
Recalling firm
- Firm
- VIRTUS PHARMACEUTICALS OPCO II L
- Notification channel
- Type
- Voluntary: Firm initiated
- Address
- 1321 Murfreesboro Pike #, N/A, Nashville, Tennessee 37217-2726
Distribution
- Quantity
- 94,643 bottles
- Distribution pattern
- Nationwide and Puerto Rico
Timeline
- Recall initiated
- 2016-09-02
- FDA classified
- 2016-12-22
- Posted by FDA
- 2016-12-28
- Terminated
- 2019-09-23
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0212-2017. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.