Drug product
Estradiol 6 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: 69761-006-01.
D-0896-2017
Product summary
- Firm
- Qualgen
- Event
- Event 77064
- Status
- Terminated
- Classification
- Class II
- Quantity
- 4,815 pellets.
- Official record key
drug-enforcement:D-0896-2017
Official wording
Reason: CGMP deviations- Lack of Quality Assurance
Code information: Lot# C046; Exp. 03/15/18 Lot# C025; Exp. 08/23/17 Lot# B159; Exp. 12/28/17 Lot# B121; Exp. 10/10/17 Lot# B118; Exp. 10/17/17 Lot# B086; Exp. 08/29/17 Lot# B068; Exp. 07/11/17 Lot# B053; Exp. 06/14/17 Lot# B034; Exp. 04/26/17
Distribution pattern: Nationwide.
Derived failure modes
-
Manufacturing or process control
CGMP deviations