Recall: D-1060-2020

Class II - Potentially Harmful

Class IIClassification

2020-03-19Initiated

TerminatedStatus

PAI Holdings, LLC. dba PharmacFirm

Product

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

Reason

SubPotent Drug: Low out-of-specification results for assay testing.

Distribution

Nationwide in the USA.

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