Drug product
Estriol USP Micronized 5 G, Rx only, Triova 115 W 3rd Street Suite 720 Tulsa, OK 74103, NDC 71092-9977-02
D-1284-2020
Product summary
- Event
- Event 85704
- Status
- Terminated
- Classification
- Class II
- Quantity
- 210 grams
- Official record key
drug-enforcement:D-1284-2020
Official wording
Reason: Failed impurities/ degradation specifications: Out of specification for organic impurities.
Code information: Lot #:17010401181119190927, EXP 12/2020, 1701040118111919092725200122, EXP.12/2020
Distribution pattern: U.S.A. Nationwide
Derived failure modes
-
Potency or specification failure
Out of specification