FDA recall D-0891-2017

Qualgen · Class II · drug

Product

Estradiol 20 mg pellet 99.5% Estradiol USP, .5% Stearic Acid NF in 1 count and 12 count bottles, Sterile Office Use Only, For Subcutaneous Use Only Rx Only, Manufactured by Qualgen 14844 Bristol Park Blvd Edmond, OK 73013 NDC: 69761-020-01

Reason for recall

CGMP deviations- Lack of Quality Assurance

Distribution

Nationwide.

Key facts

Status: Terminated
Initiation date: 2017-04-19
Report date: 2017-06-14
Termination date: 2021-09-24
Voluntary/Mandated: Voluntary: Firm initiated
Location: Edmond, OK, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0891-2017