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Qualgen recalls Estradiol 12.5 mg pellet 99.5% Estradiol USP, .5% Stearic Acid NF in 1 count, 12 count, and 30 count bottles, Sterile Of

Recalled June 14, 2017 · FDA recall D-0894-2017 · Qualgen

Hazard
CGMP deviations- Lack of Quality Assurance · FDA Class II
Units
4,883 pellets.
Sold at
Nationwide.

Description

CGMP deviations- Lack of Quality Assurance

Product
Estradiol 12.5 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: 69761-012-01
Manufacturer(s)
Qualgen

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov