FDA recall D-0721-2021

PAI Holdings, LLC. dba Pharmaceutical Associates Inc · Class II · drug

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 for recall

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

Distribution

Distributed Nationwide in the USA

Key facts

Status: Terminated
Initiation date: 2021-07-29
Report date: 2021-08-18
Termination date: 2022-12-02
Voluntary/Mandated: Voluntary: Firm initiated
Location: Greenville, SC, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0721-2021