PlainRecalls
FDA Drug Moderate Class II Ongoing

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

Reported: May 3, 2023 Initiated: March 16, 2023 #D-0549-2023

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

Details

Units Affected
6 bottles
Distribution
Nationwide with the United States
Location
Indianapolis, IN

Frequently Asked Questions

What product was recalled?
BusPIRone Hydrochloride Tablets USP, 7.5 mg, 30-count bottles, Rx Only, Repackaged By: NOrthwind Pharmaceuticals, Indianapolis, IN 46203. NDC 51655-511-52. Recalled by Northwind Pharmaceuticals LLC. Units affected: 6 bottles.
Why was this product recalled?
CGMP Deviations
Which agency issued this recall?
This recall was issued by the FDA Drug on May 3, 2023. Severity: Moderate. Recall number: D-0549-2023.