Agency classClass IIOur severity:Moderate FDA (Drugs)·D-927-2014·Announced 2014-01-29

Aidapak Recalls Aspirin Chew Tablets Due to Potential Label Mixup

Aidapak Services is recalling 81 mg aspirin chew tablets because they may have been mislabeled as other medications, including modafinil and omega-3 fatty acids.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II and involves a labeling mixup. Per the rubric, minor labeling errors and voluntary precautionary recalls without reported injuries are rated as Moderate.

Plain-English summary

Aidapak Services, LLC is recalling 4,246 units of ASPIRIN, CHEW Tablet, 81 mg, Over The Counter (NDC 00536329736). The recall is due to a labeling error where the aspirin tablets may have been mislabeled as other drugs, specifically OMEGA-3 FATTY ACID, Capsule, 1000 mg, or MODAFINIL, Tablet, 200 mg.

The affected repacked drugs were distributed in Arizona, California, Oregon, and Washington. The source text lists specific pedigree codes and expiration dates for the affected aspirin units, including AD33897_1 (EXP: 5/9/2014), W002773 (EXP: 6/6/2014), W003093 (EXP: 6/13/2014), W003459 (EXP: 6/20/2014), and AD49582_1 (EXP: 5/16/2014).

Consumers should check their medication labels to ensure they are taking the correct product. If a label indicates a different drug than what is in the bottle, or if the product matches the recalled NDC and pedigree codes, consumers should stop using the product and contact their pharmacist or the recalling firm for instructions.

The recalled product

Product: ASPIRIN, CHEW Tablet, 81 mg, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 00536329736.
Manufacturer: Aidapak Services, LLC
Category: Drug — Over-the-Counter Medication
Hazard: mis-labeling
Affected units: 4,246

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (12)

ASPIRIN
CHEW Tablet
81 mg has the following codes: Pedigree: AD33897_1
EXP: 5/9/2014
Pedigree: W002773
EXP: 6/6/2014
Pedigree: W003093
EXP: 6/13/2014
Pedigree: W003459
EXP: 6/20/2014
Pedigree: AD49582_1
EXP: 5/16/2014.

Distribution

Distributed in 4 states:

Part of a larger recall action

This product is one of 265 recalled by Aidapak Services, LLC under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 265 products in this recall →

Same manufacturer · Aidapak Services, LLC

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Same hazard · mis labeling