Drug product
Estradiol 18 mg pellet , 99.5% Estradiol USP, .5% Stearic Acid NF in 1 count, 12 count, and 30 count bottles, Sterile Office Use Only, Subcutaneous Use Only, Rx Only, Manufactured by: Qualgen 14844 Bristol Park Blvd Edmond, OK 73013 NDC: 69761-018-01.
D-0892-2017
Product summary
- Firm
- Qualgen
- Event
- Event 77064
- Status
- Terminated
- Classification
- Class II
- Quantity
- 6,361 pellets.
- Official record key
drug-enforcement:D-0892-2017
Official wording
Reason: CGMP deviations- Lack of Quality Assurance
Code information: Lot# C018; Exp. 08/2/17 Lot# B151; Exp. 12/7/17 Lot# B108; Exp. 10/3/17 Lot# B095; Exp. 09/12/17 Lot# B062; Exp. 07/6/17 Lot# B035; Exp. 05/2/17 Lot# B133; Exp. 11/4/17
Distribution pattern: Nationwide.
Derived failure modes
-
Manufacturing or process control
CGMP deviations