FDA recall D-0889-2017

Product

Estradiol 25 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 69761-025-01,

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-0889-2017