Drug product
Estradiol 25 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 69761-025-01,
D-0889-2017
Product summary
- Firm
- Qualgen
- Event
- Event 77064
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1,153 pellets.
- Official record key
drug-enforcement:D-0889-2017
Official wording
Reason: CGMP deviations- Lack of Quality Assurance
Code information: Lot # C031; Exp. 03/2/18 Lot # B077; Exp. 08/10/17 Lot # B040; Exp. 05/16/17
Distribution pattern: Nationwide.
Derived failure modes
-
Manufacturing or process control
CGMP deviations