Drug product
NYSTATIN Oral Suspension, USP 500,000 Units/5mL, unit dose 5ml cups, packaged in a) 50 unit dose cups (10x5ml unit dose cups per tray, 5 trays per case) NDC 66689-037-50; b) 100 unit dose cups (10x5ml unit dose cups per tray, 10 trays per case) NDC 66689-037-99. Rx Only, Manufactured by VistaPharm, Inc. Largo, FL 33771
D-0348-2019
Product summary
- Firm
- VistaPharm, Inc.
- Event
- Event 81684
- Status
- Terminated
- Classification
- Class III
- Quantity
- 4,065,550 5 ml cups
- Official record key
drug-enforcement:D-0348-2019
Official wording
Reason: Failed Impurities/Degradation Specifications:Out of specification for impurities.
Code information: Lots: a) 505300 Exp. Dec 2018; 522200 Exp. Apr 2019; 534400 Exp. Jul 2019; 539000 Exp. Aug 2019; 543400 Exp. Sep 2019; b) 523600, 522200X Exp. Apr 2019; 535500 Exp. Jul 2019; 540700 Exp. Aug 2019; 543300 Exp. Sep 2019; 550100 Exp. Oct 2019.
Distribution pattern: Nationwide in the USA and Puerto Rico
Derived failure modes
-
Potency or specification failure
Out of specification