Drug product
Estradiol 20 mg pellet 99.5% Estradiol USP, .5% Stearic Acid NF in 1 count and 12 count bottles, Sterile Office Use Only, For Subcutaneous Use Only Rx Only, Manufactured by Qualgen 14844 Bristol Park Blvd Edmond, OK 73013 NDC: 69761-020-01
D-0891-2017
Product summary
- Firm
- Qualgen
- Event
- Event 77064
- Status
- Terminated
- Classification
- Class II
- Quantity
- 4,468 pellets.
- Official record key
drug-enforcement:D-0891-2017
Official wording
Reason: CGMP deviations- Lack of Quality Assurance
Code information: Lot# C022; Exp. 08/21/17 Lot# B143; Exp. 11/22/17 Lot# B104; Exp. 09/27/17 Lot# B073; Exp. 08/1/17 Lot# B052; Exp. 06/13/17
Distribution pattern: Nationwide.
Derived failure modes
-
Manufacturing or process control
CGMP deviations