Recall: D-0824-2020

Class II - Potentially Harmful

Class IIClassification

2020-01-14Initiated

TerminatedStatus

Pharmaceutical Associates IncFirm

Product

Nystatin Oral Suspension, USP 100,000 units per mL Cherry/Peppermint Flavor, 16 fl oz (473 mL) Rx Only, pai, Pharmaceutical Associates, Inc. Greenville, SC 29605. NDC 0121-0810-16

Reason

Subpotent: Out of specification for assay at the 12-month time point.

Distribution

Distributed Nationwide in the US

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