Acetaminophen Extra Strength Tablets, 500 mg each, 100 count bottles, Packaged By: A-S Medication Solutions, Libertyvill
Summary
The FDA issued a Class I for Acetaminophen Extra Strength Tablets, 500 mg each, 100 count bottles, Packaged B by A-S Medication Solutions LLC. Reason: Labeling: Label Mix-Up: Some bottles of Acetaminophen Extra Strength 500 mg tablets were incorrectly labeled with the drug facts label for Aspirin 81 .
Details
Source
Drug Recall
External ID
D-0631-2024
Action Date
2024-08-14
Status
Terminated
Category
drug
Product Description
Acetaminophen Extra Strength Tablets, 500 mg each, 100 count bottles, Packaged By: A-S Medication Solutions, Libertyville, IL 60048. NDC: 50090-5313-2
Lot/Code Info: Lot: 4138197; Exp 10/31/2025
Quantity Affected: 429 bottles
Reason for Recall
Labeling: Label Mix-Up: Some bottles of Acetaminophen Extra Strength 500 mg tablets were incorrectly labeled with the drug facts label for Aspirin 81 mg tablets.
Distribution
Nationwide within the United States.
Type: Voluntary: Firm initiated
Recall Initiated: 2024-06-21
Company
Libertyville, IL
Context & Analysis
This is a Class I recall. Class I recalls are the most serious — there is a reasonable probability that use of or exposure to the product will cause serious health consequences or death.
This was one of 59 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
A-S Medication Solutions LLC has 3 FDA actions in our database, including 3 recalls.
Frequently Asked Questions
What is a Class I recall?
A Class I recall is the most serious type. The FDA has determined there is a reasonable probability that the product will cause serious adverse health consequences or death. Consumers should stop using the product immediately.
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 (A-S Medication Solutions LLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does A-S Medication Solutions LLC have FDA actions?
A-S Medication Solutions LLC has 3 FDA actions in our database, including 3 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0631-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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