Drug 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
D-0894-2017
Product summary
- Firm
- Qualgen
- Event
- Event 77064
- Status
- Terminated
- Classification
- Class II
- Quantity
- 4,883 pellets.
- Official record key
drug-enforcement:D-0894-2017
Official wording
Reason: CGMP deviations- Lack of Quality Assurance
Code information: Lot# C044; Exp. 03/14/18 Lot# C013; Exp. 07/23/17 Lot# B150; Exp. 12/6/17 Lot# B119; Exp. 10/18/17 Lot# B097; Exp. 09/14/17 Lot# B061; Exp. 07/5/17
Distribution pattern: Nationwide.
Derived failure modes
-
Manufacturing or process control
CGMP deviations