VistaPharm, Inc. recalls Nystatin Oral Suspension, USP, 100,000 units/mL, packaged in a) 2 fl.oz. (60mL) bottles (NDC 66689-008-02), and 500,000…

Recall date

May 17, 2017

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

D-0869-2017

FDA classification

Class III

Brand / firm

VistaPharm, Inc.

Sold / distributed

Nationwide in the US and Puerto Rico

Why it was recalled

Failed Impurities/Degradation Specifications: Presence of an impurity peak that exceeds approved specification.

Class III means the product violates regulations but is not likely to cause harm.

What 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.