Drug product
Estradiol 15mg pellet, 1 count (NDC 69761-015-01), 6 count (NDC 69761-015-06), 12 count (NDC 69761-015-12), and 30 count (NDC 69761-015-30) vials, Rx Only, Qualgen, LLC, Edmond, OK 73013
D-0227-2019
Product summary
- Firm
- Qualgen, LLC
- Event
- Event 81346
- Status
- Terminated
- Classification
- Class II
- Quantity
- Unavailable
- Official record key
drug-enforcement:D-0227-2019
Official wording
Reason: Lack of Assurance of Sterility
Code information: Lots: C253 BUD: 12/12/2018; D016 BUD: 1/18/2019
Distribution pattern: Nationwide.
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility