Qualgen recalls Estradiol 20 mg pellet 99.5% Estradiol USP, .5% Stearic Acid NF in 1 count and 12 count bottles, Sterile Office Use Only
Recalled June 14, 2017 · FDA recall D-0891-2017 · Qualgen
Hazard
CGMP deviations- Lack of Quality Assurance · FDA Class II
Units
4,468 pellets.
Sold at
Nationwide.
Description
CGMP deviations- Lack of Quality Assurance
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
Manufacturer(s)
Qualgen
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →