NYSTATIN Oral Suspension, USP 500,000 Units/5mL, unit dose 5ml cups, packaged in a) 50 unit dose ...
FDA Recall #D-0348-2019 — Class III — November 30, 2018
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.
Recalling Firm
VistaPharm, Inc. — Largo, FL
Classification
Class III — Not likely to cause adverse health consequences.
Product Type
Drugs
Product Quantity
4,065,550 5 ml cups
Distribution
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.
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated