Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Labeling: Label Mixup; ACETAMINOPHEN/ ASPIRIN/ CAFFEINE, Tablet, 250 mg/250 mg/65 mg may be potentially mislabeled as NAPROXEN, Tablet, 500 mg, NDC 53746019001, Pedigree: AD68025_8, EXP: 5/28/2014.
ACETAMINOPHEN/ ASPIRIN/ CAFFEINE, Tablet, 250 mg/250 mg/65 mg, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 00904513559
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
Reason Failed Tablet/Capsule Specification: There is a potential for the imprint to be missing on tablets.
Reason Failed Tablet/Capsule Specification: There is a potential for the imprint to be missing on tablets.
Reason Defective Container
Reason Labeling: Label Mix-up. This issue affects the outer box labeling only. The box incorrectly states the ingredients Acetaminophen 500mg and Caffeine…
Reason Discoloration
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