D-0869-2017 Class III Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- June 7, 2017
- Initiation Date
- May 17, 2017
- Termination Date
- January 13, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2,208,500 cups/18696 bottles
Product Description
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.
Reason for Recall
Failed Impurities/Degradation Specifications: Presence of an impurity peak that exceeds approved specification.
Distribution Pattern
Nationwide in the US and Puerto Rico
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.