PlainRecalls
FDA Drug Low Class III Terminated

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.

Reported: June 7, 2017 Initiated: May 17, 2017 #D-0869-2017

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.

Details

Recalling Firm
VistaPharm, Inc.
Units Affected
2,208,500 cups/18696 bottles
Distribution
Nationwide in the US and Puerto Rico
Location
Largo, FL

Frequently Asked Questions

What product was recalled? ▼
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.. Recalled by VistaPharm, Inc.. Units affected: 2,208,500 cups/18696 bottles.
Why was this product recalled? ▼
Failed Impurities/Degradation Specifications: Presence of an impurity peak that exceeds approved specification.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on June 7, 2017. Severity: Low. Recall number: D-0869-2017.

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