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

FDA recall notice · announced September 2, 2020 · Par Pharmaceutical

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

The product

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

Reason for recall

Failed Impurity /Degradation Specifications

Notes

Distribution: Product was distributed to 9 major distributors throughout the United States.
Lot/code information: Lot # 32091002, exp. date May 2021
Quantity: 11,347 bottles
Status: Terminated
Products in this recall event:
- BusPIRone Hydrochloride Tablets, USP 7.5 mg NDC# 49884-725-01 (D-1542-2020)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.