FDA recall D-0228-2019

Qualgen, LLC · Class II · drug

Product

Estradiol 18mg pellet, 1 count (NDC 69761-018-01), 6 count (NDC 69761-018-06), 12 count (NDC 69761-018-12), and 30 count (NDC 69761-018-30) vials, Rx Only, Qualgen, LLC, Edmond, OK 73013

Reason for recall

Lack of Assurance of Sterility

Distribution

Nationwide.

Key facts

Status: Terminated
Initiation date: 2018-10-17
Report date: 2018-11-14
Termination date: 2020-06-04
Voluntary/Mandated: Voluntary: Firm initiated
Location: Edmond, OK, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0228-2019