Recall: D-1494-2020

Class II - Potentially Harmful

Class IIClassification

2020-08-04Initiated

TerminatedStatus

PAI Holdings, LLC. dba PharmacFirm

Product

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

Reason

Subpotent drug: Out of specification for assay at the 15-month test interval.

Distribution

Nationwide 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.