Drug product
Nystatin Oral Suspension, USP 500,000 units/5mL Cup, Delivers 5 mL, Rx Only, Manufactured by: VistaPharm, Largo, FL 33771, a) NDC 66689-037-50 (individual cup NDC: 66689-037-01); b) 66689-037-99.
D-1377-2020
Product summary
- Firm
- VistaPharm, Inc.
- Event
- Event 85888
- Status
- Terminated
- Classification
- Class III
- Quantity
- 380,700 cups
- Official record key
drug-enforcement:D-1377-2020
Official wording
Reason: Failed impurities/degradation products; Presence of an impurity peak that exceeds the approved specification.
Code information: Lot #: a) 619800, Exp. 12/31/2020; 626200, Exp. 01/31/2021; b) 619800X,Exp. 12/31/2020; 626200X, Exp. 01/31/2021.
Distribution pattern: United States including Puerto Rico
Derived failure modes
-
Unknown
Failed impurities/degradation products; Presence of an impurity peak that exceeds the approved specification.