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.
Reason for recall: CGMP deviations- Lack of Quality Assurance
Recall initiated: 20170419
Status: Terminated
Classification: Class II
Recall type: Voluntary: Firm initiated