Qualgen recalls Estradiol 6 mg pellet 99.5% Estradiol USP, .5% Stearic Acid NF in 1 count, 12 count, and 30 count bottles, Sterile Offic
Recalled June 14, 2017 · FDA recall D-0896-2017 · Qualgen
Hazard
CGMP deviations- Lack of Quality Assurance · FDA Class II
Units
4,815 pellets.
Sold at
Nationwide.
Description
CGMP deviations- Lack of Quality Assurance
Product
Estradiol 6 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: 69761-006-01.
Manufacturer(s)
Qualgen
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →