Acetaminophen Extra Strength 500 mg, 100 Tablets per bottle, Akron Pharma, Inc., 373 RT US 46 W Building E, Suite 117, F
Summary
The FDA issued a Class III for Acetaminophen Extra Strength 500 mg, 100 Tablets per bottle, Akron Pharma, Inc., by Akron Pharma, Inc.. Reason: Labeling: Not Elsewhere Classified: Tablets/Capsules imprinted with wrong ID..
Details
Source
Drug Recall
External ID
D-0193-2025
Action Date
2025-01-22
Status
Ongoing
Category
drug
Product Description
Acetaminophen Extra Strength 500 mg, 100 Tablets per bottle, Akron Pharma, Inc., 373 RT US 46 W Building E, Suite 117, Fairfield, NJ 07004, NDC 71399-8022-01.
Lot/Code Info: Lot: KDT0224002A, Exp 09/30/2026
Quantity Affected: 768 bottles
Reason for Recall
Labeling: Not Elsewhere Classified: Tablets/Capsules imprinted with wrong ID.
Distribution
Nationwide in the US
Type: Voluntary: Firm initiated
Recall Initiated: 2024-12-12
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 99 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-0193-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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