Drug product
Estradiol 22 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 69761-022-01
D-0890-2017
Product summary
- Firm
- Qualgen
- Event
- Event 77064
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1,666 pellets.
- Official record key
drug-enforcement:D-0890-2017
Official wording
Reason: CGMP deviations- Lack of Quality Assurance
Code information: Lot # B128; Exp. 11/1/17 Lot # B075; Exp. 08/3/17
Distribution pattern: Nationwide.
Derived failure modes
-
Manufacturing or process control
CGMP deviations