Drug Enforcement D-0454-2023

Labeling: Incorrect or Missing Lot and/or Exp Date

Status

Terminated

Classification

Class III

Report Date

March 15, 2023

Termination Date

September 9, 2024

Product Information

Product description
DIBUCAINE 1% HEMORRHOIDAL OINTMENT, 1 oz. (28 gm), Manufactured for: Akron Pharma Inc. Fairfield NJ 07004, NDC 71399-2829-1
Product quantity
4,416 tubes
Reason for recall
Labeling: Incorrect or Missing Lot and/or Exp Date
Recall initiation reason
—
Initial firm notification
Letter
Distribution pattern
Nationwide within the United States

Location & Firm

Recalling firm
Akron Pharma, Inc.
Address
373 Us Highway 46 Ste 117

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date
—

Codes & Dates

Recall number
D-0454-2023
Event ID
91785
Recall initiation date
February 17, 2023
Center classification date
March 9, 2023
Code info
Lot #: 2206016, Exp. date 05/2024
More code info
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