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Recall Observatory FDA recall evidence

Drug product

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

D-0454-2023

February 17, 2023

Class III

Product summary

Firm
Akron Pharma, Inc.
Event
Event 91785
Status
Terminated
Classification
Class III
Quantity
4,416 tubes
Official record key
drug-enforcement:D-0454-2023

Official wording

Reason: Labeling: Incorrect or Missing Lot and/or Exp Date

Code information: Lot #: 2206016, Exp. date 05/2024

Distribution pattern: Nationwide within the United States

Derived failure modes

  • Labeling or packaging

    reason.labeling_packaging · v1.0.0

    Labeling: Incorrect or Missing