FDA-Drug2017-06-14Class II
Estradiol 15 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: 69761-015-01
Qualgen
Hazard
CGMP deviations- Lack of Quality Assurance
Sold states
Nationwide.
Affected count
6,227 pellets
Manufactured in
14844 Bristol Park Blvd, N/A, Edmond, OK, United States
Products
Estradiol 15 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: 69761-015-01
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0893-2017Don't want to check this manually?
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