Recalls / Class II
Class IID-342-2014
Product
Phenytoin Oral Suspension USP 125mg/5mL, 50 cups per case, For Oral Administration Only, Rx Only, Manufactured by: VistaPharm Inc, Largo, FL 33771, NDC 66689-036-50
- Affected lot / code info
- Lots #'s: 268200, Exp 06/14; 274600, Exp 08/14; 279500, Exp 09/14; 290700, Exp 12/14; 296700, Exp 02/15; 305100, Exp 06/15
Why it was recalled
Defective Container: A lidding deformity allowed for the product to have out of specification results for assay and viscosity at the12 month stability timepoint.
Recalling firm
- Firm
- VistaPharm, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 7265 Ulmerton Rd, Largo, Florida 33771-4809
Distribution
- Quantity
- 27,788 cases
- Distribution pattern
- Nationwide and Puerto Rico
Timeline
- Recall initiated
- 2013-10-15
- FDA classified
- 2013-12-06
- Posted by FDA
- 2013-12-18
- Terminated
- 2016-09-28
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-342-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.