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Acetaminophen Extra Strength Tablets, 500 mg each, 100 count bottles, Packaged By: A-S Medication Solutions, Libertyville, IL 60048. NDC: 50090-5313-2

Drug Recall

Official source record

Recall number
D-0631-2024
Event ID
94873
Classification
Class I
Status
Terminated
Recalling company
A-S Medication Solutions LLC
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.
Report date
August 14, 2024
Recall initiation date
June 21, 2024
Termination date
May 7, 2025
Distribution pattern
Nationwide within the United States.

Drug product identifiers

Manufacturer
A-S Medication Solutions
Brand name
ACETAMINOPHEN
Generic name
ACETAMINOPHEN
Substance name
ACETAMINOPHEN
Product NDC
50090-5313
Package NDCs
50090-5313-1; 50090-5313-2; 50090-5313-3; 50090-5313-4; 50090-5313-5
Route
ORAL

Where this information comes from

View FDA enforcement record -- the specific openFDA drug enforcement record this summary was built from.

FDA Enforcement Reports -- FDA's general, official recall and enforcement information.

Drug recall information is sourced from the FDA's structured openFDA Enforcement Reports. Newly announced recalls may appear on FDA.gov before they become available in the structured dataset. See Methodology for details.

Retrieved by Public Health Trace:

Frequently asked questions

What does a Class I mean?

A situation in which there is a reasonable probability that use of or exposure to a product will cause serious adverse health consequences or death.

Is this recall still active?

According to the FDA, this recall's status is "Terminated." Always confirm the current status using the source links below, since status can change after Public Health Trace last retrieved this record.

What should I do if I have this medication?

Do not start, stop, or change any medication based on this page. Follow the instructions published by the FDA and the recalling company (see the source links below), and talk to your pharmacist or physician if you have questions about a specific medication.

Where can I find more official information?

The source links below, published by the FDA, are the authoritative record for this recall, including any updates issued after this summary was retrieved.

Public Health Trace republishes official FDA drug recall information -- it is not affiliated with the FDA, does not verify or supplement what the source has published, and does not provide medical advice. Never start, stop, or change a medication based on this page. Always follow the guidance of your pharmacist or physician, and consult the official source links above for the most current information. Read the full medical disclaimer.