PlainRecalls
FDA Drug Moderate Class II Terminated

BusPIRone Hydrochloride Tablets, USP 7.5 mg NDC# 49884-725-01

Reported: September 2, 2020 Initiated: August 10, 2020 #D-1542-2020

Product Description

BusPIRone Hydrochloride Tablets, USP 7.5 mg NDC# 49884-725-01

Reason for Recall

Failed Impurity /Degradation Specifications

Details

Recalling Firm
Par Pharmaceutical Inc.
Units Affected
11,347 bottles
Distribution
Product was distributed to 9 major distributors throughout the United States.
Location
Chestnut Ridge, NY

Frequently Asked Questions

What product was recalled?
BusPIRone Hydrochloride Tablets, USP 7.5 mg NDC# 49884-725-01. Recalled by Par Pharmaceutical Inc.. Units affected: 11,347 bottles.
Why was this product recalled?
Failed Impurity /Degradation Specifications
Which agency issued this recall?
This recall was issued by the FDA Drug on September 2, 2020. Severity: Moderate. Recall number: D-1542-2020.