PlainRecalls
FDA Drug Moderate Class II Completed

BusPIRone Hydrochloride Tablets, USP, 15 mg, 100-count bottle, Rx only, Manufactured By: Oxford Pharmaceuticals, LLC Birmingham, Alabama 35211, NDC 69584-093-10

Reported: June 9, 2021 Initiated: May 5, 2021 #D-0602-2021

Product Description

BusPIRone Hydrochloride Tablets, USP, 15 mg, 100-count bottle, Rx only, Manufactured By: Oxford Pharmaceuticals, LLC Birmingham, Alabama 35211, NDC 69584-093-10

Reason for Recall

Presence of Foreign Tablets/Capsules

Details

Units Affected
6,864 bottles
Distribution
USA Nationwide.
Location
Birmingham, AL

Frequently Asked Questions

What product was recalled?
BusPIRone Hydrochloride Tablets, USP, 15 mg, 100-count bottle, Rx only, Manufactured By: Oxford Pharmaceuticals, LLC Birmingham, Alabama 35211, NDC 69584-093-10. Recalled by Oxford Pharmaceuticals, LLC. Units affected: 6,864 bottles.
Why was this product recalled?
Presence of Foreign Tablets/Capsules
Which agency issued this recall?
This recall was issued by the FDA Drug on June 9, 2021. Severity: Moderate. Recall number: D-0602-2021.