Drug product
Nystatin Oral Suspension, USP 500,000 units/ 5 mL (NDC 66689-037-01 ) Rx Only, Manufactured by VistaPharm, Inc. Largo, FL 33771
D-913-2013
Product summary
- Firm
- VistaPharm, Inc.
- Event
- Event 65756
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1,707,050 cups / 5ml ea.
- Official record key
drug-enforcement:D-913-2013
Official wording
Reason: Failed Impurites/Degradation Specifications: Test failure of single largest peak at 18 months.
Code information: Lot # 240200, 243000, 244800, 245600, 250800 and 253600. Exp 06/13.
Distribution pattern: Nationwide.
Derived failure modes
-
Unknown
Failed Impurites/Degradation Specifications: Test failure of single largest peak at 18 months.