FDA recall D-0631-2024

Product

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

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.

Key facts

Status

Terminated

Initiation date

2024-06-21

Report date

2024-08-14

Termination date

2025-05-07

Voluntary/Mandated

Voluntary: Firm initiated

Location

Libertyville, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0631-2024