FDA recall D-0894-2017

Qualgen · Class II · drug

Product

Estradiol 12.5 mg pellet 99.5% Estradiol USP, .5% Stearic Acid NF in 1 count, 12 count, and 30 count bottles, Sterile Office Use Only, For Subcutaneous Use Only, Rx Only, Manufactured by: Qualgen 14844 Bristol Park Blvd Edmond, OK 73013, NDC: 69761-012-01

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-0894-2017