FDA recall D-1875-2019
AVKARE Inc. · Class II · drug
Product
AVKARE Fexofenadine Hydrochloride Tablets USP Antihistamine 180 mg, 500 Tablets per bottle, NDC 42291-297-50.
Reason for recall
Failed Stability Specifications.
Distribution
Nationwide in the U.S.
Key facts
- Status
- Terminated
- Initiation date
- 2019-08-28
- Report date
- 2019-09-18
- Termination date
- 2021-10-27
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- Pulaski, TN, United States
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1875-2019