BusPIRone Hydrochloride Tablets USP, 7.5 mg, 30-count bottles, Rx Only, Repackaged By: NOrthwind ...

FDA Recall #D-0549-2023 — Class II — March 16, 2023

Recall #D-0549-2023 Date: March 16, 2023 Classification: Class II Status: Ongoing

Product Description

BusPIRone Hydrochloride Tablets USP, 7.5 mg, 30-count bottles, Rx Only, Repackaged By: NOrthwind Pharmaceuticals, Indianapolis, IN 46203. NDC 51655-511-52

Reason for Recall

CGMP Deviations

Recalling Firm

Northwind Pharmaceuticals LLC — Indianapolis, IN

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Drugs

Product Quantity

6 bottles

Distribution

Nationwide with the United States

Code Information

Lot#: F117312201, Exp. Date 06/30/2024

Status

Ongoing

Voluntary / Mandated

Voluntary: Firm initiated