FDA recall D-0226-2019

Product

Estradiol 12.5mg pellet, 1 count (NDC 69761-012-01), 6 count (NDC 69761-012-06), 12 count (NDC 69761-012-12), and 30 count (NDC 69761-012-30) 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-0226-2019