February 2023 FDA Recall Dibucaine by Akron Pharma, Inc.
D-0454-2023 - Labeling

This Class III drug recall was voluntarily initiated by Akron Pharma, Inc. on February 17, 2023 for the product Dibucaine. The FDA reported the reason for recall as labeling. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-0454-2023

Reason for Recall
Labeling: Incorrect or Missing Lot and/or Exp Date
Initiated
02-17-2023
Reported
03-15-2023
Quantity
4,416 tubes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
91785
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Akron Pharma, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide within the United States
Termination Date About Termination Date
Date that FDA officially terminated the recall.
09-09-2024
Product Description About Product Description
Full technical description of the product.
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

71399-2829-1 Dibucaine
71399-2829-2 Dibucaine