FDA recall D-0892-2017

Product

Estradiol 18 mg pellet , 99.5% Estradiol USP, .5% Stearic Acid NF in 1 count, 12 count, and 30 count bottles, Sterile Office Use Only, Subcutaneous Use Only, Rx Only, Manufactured by: Qualgen 14844 Bristol Park Blvd Edmond, OK 73013 NDC: 69761-018-01.

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-0892-2017