Drug 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
D-342-2014
Product summary
- Firm
- VistaPharm, Inc.
- Event
- Event 66945
- Status
- Terminated
- Classification
- Class II
- Quantity
- 27,788 cases
- Official record key
drug-enforcement:D-342-2014
Official wording
Reason: Defective Container: A lidding deformity allowed for the product to have out of specification results for assay and viscosity at the12 month stability timepoint.
Code information: 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
Distribution pattern: Nationwide and Puerto Rico
Derived failure modes
-
Potency or specification failure
out of specification