Drug product
Estradiol 10 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: 69761-010-01
D-0895-2017
Product summary
- Firm
- Qualgen
- Event
- Event 77064
- Status
- Terminated
- Classification
- Class II
- Quantity
- 5,260 pellets.
- Official record key
drug-enforcement:D-0895-2017
Official wording
Reason: CGMP deviations- Lack of Quality Assurance
Code information: Lot# C021; Exp. 08/20/17 Lot# B160, Exp. 12/29/17 Lot# B140; Exp. 11/15/17 Lot# B107; Exp. 09/29/17 Lot# B079; Exp. 08/15/17 Lot# B046; Exp. 06/01/17
Distribution pattern: Nationwide.
Derived failure modes
-
Manufacturing or process control
CGMP deviations