D-1542-2020 Class II Terminated
FDA drug recall D-1542-2020 was initiated by Par Pharmaceutical Inc. on August 10, 2020 and is designated Class II. Reason for recall: Failed Impurity /Degradation Specifications The recall status is terminated (terminated June 7, 2021). Affected quantity: 11,347 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- September 2, 2020
- Initiation Date
- August 10, 2020
- Termination Date
- June 7, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 11,347 bottles
Product Description
BusPIRone Hydrochloride Tablets, USP 7.5 mg NDC# 49884-725-01
Reason for Recall
Failed Impurity /Degradation Specifications
Distribution Pattern
Product was distributed to 9 major distributors throughout the United States.
Code Information
Lot # 32091002, exp. date May 2021