FDA recall D-0865-2018

Product

Nystatin Oral Suspension, USP, 500,000 units/5 mL, For Institutional Use Only, packaged in 5 mL cups, Rx Only, Pharmaceutical Associates, Inc. Greenville, SC 29605, NDC 0121-4810-05

Reason for recall

Resuspension problems: Out of specification for appearance and resuspendability.

Distribution

Nationwide

Key facts

Status

Terminated

Initiation date

2018-05-29

Report date

2018-06-13

Termination date

2020-01-13

Voluntary/Mandated

Voluntary: Firm initiated

Location

Greenville, SC, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0865-2018