Dibucaine Ointment
FDA Recall NDC 71399-2829
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 Dibucaine (NDC 71399-2829). A significant event, classified as Class III, was initiated on Feb 17, 2023 by Akron Pharma Inc.. The reported reason for this action was: "Labeling: Incorrect or Missing Lot and/or Exp Date"
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
Class III Terminated
Labeling: Incorrect or Missing Lot and/or Exp Date
Feb 17, 2023
Mar 15, 2023
4,416 tubes
Recall Profile & Regulatory Data
Event ID
91785
Classification
Class III
Enforcement Status
Terminated
Recalling Firm
Akron Pharma, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide within the United States
Termination Date
Sep 09, 2024
Product Description
DIBUCAINE 1% HEMORRHOIDAL OINTMENT, 1 oz. (28 gm), Manufactured for: Akron Pharma Inc. Fairfield NJ 07004, NDC 71399-2829-1
Batch or Lot Expiration Information
Lot# : 2206016, Exp. date 05/2024
Affected Packages Involved in this Recall
71399-2829-1Product
71399-2829-2Product
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.
