FDA recall D-0869-2017

VistaPharm, Inc. · Class III · drug

Product

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

Nationwide in the US and Puerto Rico

Key facts

Status: Terminated
Initiation date: 2017-05-17
Report date: 2017-06-07
Termination date: 2020-01-13
Voluntary/Mandated: Voluntary: Firm initiated
Location: Largo, FL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0869-2017