FDA recall D-1284-2020
TRIOVA PHARMACEUTICALS LLC · Class II · drug
Product
Estriol USP Micronized 5 G, Rx only, Triova 115 W 3rd Street Suite 720 Tulsa, OK 74103, NDC 71092-9977-02
Reason for recall
Failed impurities/ degradation specifications: Out of specification for organic impurities.
Distribution
U.S.A. Nationwide
Key facts
- Status
- Terminated
- Initiation date
- 2020-05-15
- Report date
- 2020-06-10
- Termination date
- 2023-06-01
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- Tulsa, OK, United States
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1284-2020