FDA-Drug2018-06-13Class III

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

Pharmaceutical Associates Inc
Hazard

Resuspension problems: Out of specification for appearance and resuspendability.

Sold states
Nationwide
Affected count
275400 cups
Manufactured in
201 Delaware St, N/A, Greenville, SC, United States
Products
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

Official notice

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

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