Recall: D-0865-2018

Class III - Minor Violations

Class IIIClassification

2018-05-29Initiated

TerminatedStatus

Pharmaceutical Associates IncFirm

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

Resuspension problems: Out of specification for appearance and resuspendability.

Distribution

Nationwide

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.