Recall: D-0721-2021

Class II - Potentially Harmful

Class IIClassification

2021-07-29Initiated

TerminatedStatus

PAI Holdings, LLC. dba PharmacFirm

Product

Nystatin Oral Suspension, USP 100,000 units per mL, Cherry/Peppermint Flavor, Rx ONLY, packaged in a) 16 fl oz (473 mL) NDC 0121-0868-16; b) 2 fl oz (60 mL) NDC 0121-0868-02; Manufactured by: Pharmaceutical Associates, Inc. Greenville, SC 29605

Reason

Lack of CGMP: This recall is being carried out due to potential for carry over of Senna Syrup.

Distribution

Distributed 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.