DIBUCAINE 1% HEMORRHOIDAL OINTMENT, 1 oz. (28 gm), Manufactured for: Akron Pharma Inc. Fairfield NJ 07004, NDC 71399-282
Summary
The FDA issued a Class III for DIBUCAINE 1% HEMORRHOIDAL OINTMENT, 1 oz. (28 gm), Manufactured for: Akron Pharm by Akron Pharma, Inc.. Reason: Labeling: Incorrect or Missing Lot and/or Exp Date.
Details
Source
Drug Recall
External ID
D-0454-2023
Action Date
2023-03-15
Status
Terminated
Category
drug
Product Description
DIBUCAINE 1% HEMORRHOIDAL OINTMENT, 1 oz. (28 gm), Manufactured for: Akron Pharma Inc. Fairfield NJ 07004, NDC 71399-2829-1
Lot/Code Info: Lot #: 2206016, Exp. date 05/2024
Quantity Affected: 4,416 tubes
Reason for Recall
Labeling: Incorrect or Missing Lot and/or Exp Date
Distribution
Nationwide within the United States
Type: Voluntary: Firm initiated
Recall Initiated: 2023-02-17
Company
Fairfield, NJ
Context & Analysis
This is a Class III recall. Class III recalls involve products unlikely to cause adverse health consequences, but that violate FDA regulations.
This was one of 126 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Akron Pharma, Inc. has 11 FDA actions in our database, including 11 recalls.
Frequently Asked Questions
What is a Class III recall?
A Class III recall involves products that are unlikely to cause adverse health effects but violate FDA labeling or manufacturing regulations.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Akron Pharma, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Akron Pharma, Inc. have FDA actions?
Akron Pharma, Inc. has 11 FDA actions in our database, including 11 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0454-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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