Drug product
BusPIRone Hydrochloride Tablets, USP 7.5 mg NDC# 49884-725-01
D-1542-2020
Product summary
- Event
- Event 86202
- Status
- Terminated
- Classification
- Class II
- Quantity
- 11,347 bottles
- Official record key
drug-enforcement:D-1542-2020
Official wording
Reason: Failed Impurity /Degradation Specifications
Code information: Lot # 32091002, exp. date May 2021
Distribution pattern: Product was distributed to 9 major distributors throughout the United States.
Derived failure modes
-
Unknown
Failed Impurity /Degradation Specifications