FDA recall D-0602-2021

Oxford Pharmaceuticals, LLC · Class II · drug

Product

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

Distribution

USA Nationwide.

Key facts

Status: Completed
Initiation date: 2021-05-05
Report date: 2021-06-09
Voluntary/Mandated: Voluntary: Firm initiated
Location: Birmingham, AL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0602-2021