Drug product
Nystatin Oral Suspension, USP, 100,000 units/mL, packaged in a) 2 fl.oz. (60mL) bottles (NDC 66689-008-02), and 500,000 units/5mL individual unit dose cup (NDC 66689-037-01) packaged in b) 50 count unit dose cups/case (NDC 66689-037-50) and c) 100 count unit dose cups/case (NDC 66689-037-99) Rx only, Manufactured by: VistaPharm, Largo, FL 33771.
D-0869-2017
Product summary
- Firm
- VistaPharm, Inc.
- Event
- Event 77319
- Status
- Terminated
- Classification
- Class III
- Quantity
- 2,208,500 cups/18696 bottles
- Official record key
drug-enforcement:D-0869-2017
Official wording
Reason: Failed Impurities/Degradation Specifications: Presence of an impurity peak that exceeds approved specification.
Code information: a) Lot #: 431300, Exp. 01/2018; b) Lot #: 434000, 432500, Exp. 07/2017;462200, Exp. 02/2018 c) Lot #: 443800, 445500, Exp. 09/2017; 460500, 461500, Exp. 01/2018.
Distribution pattern: Nationwide in the US and Puerto Rico
Derived failure modes
-
Potency or specification failure
Failed Impurities/Degradation Specifications