D-0348-2019 Class III Terminated
FDA drug recall D-0348-2019 was initiated by VistaPharm, Inc. on Nov 30, 2018 and is designated Class III. Reason for recall: Failed Impurities/Degradation Specifications:Out of specification for impurities. The recall status is terminated (terminated Nov 25, 2020). Affected quantity: 4,065,550 5 ml cups.
Recall Details
- Product Type
- Drugs
- Report Date
- Dec 26, 2018
- Initiation Date
- Nov 30, 2018
- Termination Date
- Nov 25, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 4,065,550 5 ml cups
Product Description
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
Reason for Recall
Failed Impurities/Degradation Specifications:Out of specification for impurities.
Distribution Pattern
Nationwide in the USA and Puerto Rico
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.
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0348-2019
- openFDA file date
- Nov 3, 2026
- Loaded by RegDataLab
- Nov 4, 2026