FDA recall D-1836-2019
Upsher Smith Laboratories, Inc. · Class II · drug
Product
Bexarotene Capsules, 75 mg, 100 capsules per bottle, Rx Only, Manufactured for: Upsher-Smith Laboratories, LLC, Maple Grove, MN 55369. NDC: 0832-0285-00
Reason for recall
Failed Dissolution Specifications
Distribution
KY, OH, NJ, LA
Key facts
- Status
- Terminated
- Initiation date
- 2019-07-29
- Report date
- 2019-08-28
- Termination date
- 2022-08-25
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- Maple Grove, MN, United States
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1836-2019