Class III
Terminated
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
This recall has been terminated (originally issued December 26, 2018).
- Company
- Vistapharm, Inc.
- Recall Initiated
- November 30, 2018
- Posted
- December 26, 2018
- Recall Number
- D-0348-2019
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 4,065,550 5 ml cups
- Firm Location
- Largo, FL, United States
- Official Source
- View on FDA website ↗
Reason for Recall
Failed Impurities/Degradation Specifications:Out of specification for impurities.
Distribution
Nationwide in the USA and Puerto Rico
Lot / Code Info
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.
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