FDA recall D-1542-2020
Par Pharmaceutical Inc. · Class II · drug
Product
BusPIRone Hydrochloride Tablets, USP 7.5 mg NDC# 49884-725-01
Reason for recall
Failed Impurity /Degradation Specifications
Distribution
Product was distributed to 9 major distributors throughout the United States.
Key facts
- Status
- Terminated
- Initiation date
- 2020-08-10
- Report date
- 2020-09-02
- Termination date
- 2021-06-07
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- Chestnut Ridge, NY, United States
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1542-2020