FDAClass IIIMarch 15, 2023

Dibucaine 1% Hemorrhoidal Ointment recall: Labeling Error

DIBUCAINE 1% HEMORRHOIDAL OINTMENT, 1 oz. (28 gm), Manufactured for: Akron Pharma Inc. Fairfield NJ 07004, NDC 71399-2829-1

Why was Dibucaine 1% Hemorrhoidal Ointment recalled?

Labeling: Incorrect or Missing Lot and/or Exp Date

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot #: 2206016, Exp. date 05/2024

Product
DIBUCAINE 1% HEMORRHOIDAL OINTMENT, 1 oz. (28 gm), Manufactured for: Akron Pharma Inc. Fairfield NJ 07004, NDC 71399-2829-1
Recalling firm
Akron Pharma, Inc.
Quantity
4,416 tubes
Distribution
Nationwide within the United States
Recall date
March 15, 2023
Classification
Class III
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls