Drug product
Estradiol 10mg pellet, 1 count (NDC 69761-010-01), 6 count (NDC 69761-010-06), 12 count (NDC 69761-010-12), and 30 count (NDC 69761-010-30) vials, Rx Only, Qualgen, LLC, Edmond, OK 73013
D-0225-2019
Product summary
- Firm
- Qualgen, LLC
- Event
- Event 81346
- Status
- Terminated
- Classification
- Class II
- Quantity
- Unavailable
- Official record key
drug-enforcement:D-0225-2019
Official wording
Reason: Lack of Assurance of Sterility
Code information: Lots; C262 BUD: 12/20/2018; D067 BUD: 03/21/2019; D072 BUD: 03/28/2019
Distribution pattern: Nationwide.
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility