Pharmaceutical Associates Inc recalls Nystatin Oral Suspension, USP, 500,000 units/5 mL, For Institutional Use Only, packaged in 5 mL cups, Rx Only, Pharmace…

Recall date

May 29, 2018

Source

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

Recall number

D-0865-2018

FDA classification

Class III

Brand / firm

Pharmaceutical Associates Inc

Sold / distributed

Nationwide

Why it was recalled

Resuspension problems: Out of specification for appearance and resuspendability.

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

What was recalled

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