FDA recall D-0733-2016
TexasStar Pharmacy · Class II · drug
Product
Baclofen, 2.5 mg/mL INJ, in 100 mL vial, Rx Only, TexasStar Pharmacy, Plano, Texas 75023
Reason for recall
Lack of assurance of sterility
Distribution
TX
Key facts
- Status
- Terminated
- Initiation date
- 2015-12-29
- Report date
- 2016-03-09
- Termination date
- 2016-11-17
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- Plano, TX, United States
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0733-2016