FDA recall D-0723-2021

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

Product

Ethosuximide Oral Solution USP 250 mg/5 mL, 16 fl oz (473 mL), Rx ONLY, Pharmaceutical Associates, Inc. Greenville, SC 29605, NDC 0121-0670-16

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-0723-2021