FDA recall D-1377-2020

Product

Nystatin Oral Suspension, USP 500,000 units/5mL Cup, Delivers 5 mL, Rx Only, Manufactured by: VistaPharm, Largo, FL 33771, a) NDC 66689-037-50 (individual cup NDC: 66689-037-01); b) 66689-037-99.

Reason for recall

Failed impurities/degradation products; Presence of an impurity peak that exceeds the approved specification.

Distribution

United States including Puerto Rico

Key facts

Status

Terminated

Initiation date

2020-06-23

Report date

2020-07-15

Termination date

2022-09-28

Voluntary/Mandated

Voluntary: Firm initiated

Location

Largo, FL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1377-2020