Buspirone Hydrochloride Tablet
FDA Recall NDC 69584-092
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Buspirone Hydrochloride (NDC 69584-092). A significant event, classified as Class II, was initiated on May 05, 2021 by Oxford Pharmaceuticals, Llc. The reported reason for this action was: "Presence of Foreign Tablets/Capsules"
This specific recall has a current status of COMPLETED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of COMPLETED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
Class II Completed
Presence of Foreign Tablets/Capsules
May 05, 2021
Jun 09, 2021
6,864 bottles
Recall Profile & Regulatory Data
Event ID
87873
Classification
Class II
Enforcement Status
Completed
Recalling Firm
Oxford Pharmaceuticals, LLC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
USA Nationwide.
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
Batch or Lot Expiration Information
Lot# : C21021A, Exp. 03/2023
Affected Packages Involved in this Recall
69584-091-10Product
69584-091-50Product
69584-092-10Product
69584-092-50Product
69584-093-06Product
69584-093-10Product
69584-093-50Product
69584-094-06Product
69584-094-18Product
69584-094-50Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
