Agency classClass IIOur severity:Moderate FDA (Drugs)·D-1025-2014·Announced 2014-01-29

Aidapak Recalls Aspirin EC Tablets Due to Potential Label Mixup

Aidapak Services, LLC is recalling Aspirin EC tablets because they may have been mislabeled as other medications. The repacked drugs were distributed in four western states.

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, which typically involves a situation that might cause temporary or medically reversible adverse health consequences. The hazard is a labeling error (label mixup) without reported injuries, fitting the Moderate severity criteria for minor labeling errors or voluntary precautionary recalls.

Plain-English summary

Aidapak Services, LLC is recalling specific lots of Aspirin EC, Tablet, 325 mg, Over The Counter. The recall was initiated because the tablets may have been mislabeled as other drugs, including Multivitamin/Multimineral Chew Tablets, Diltiazem HCl ER Capsules, and Aspirin Tablets. The affected product is identified by NDC 00904201360 and contains 499 tablets.

The repacked drugs were distributed in Arizona, California, Oregon, and Washington. The recall covers five specific pedigree codes with expiration dates ranging from May 9, 2014, to June 21, 2014. Consumers should check their medication packaging for these specific pedigree codes and expiration dates.

If consumers have the affected product, they should stop using it and contact their pharmacist or the recalling firm for instructions on how to return the product. This recall is a precautionary measure to prevent patients from taking the wrong medication.

The recalled product

Product: ASPIRIN EC, Tablet, 325 mg, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 00904201360.
Manufacturer: Aidapak Services, LLC
Category: Drug — Over-the-Counter Medication
Hazard: mis-labeling
Affected units: 499

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 EC
Tablet
325 mg has the following codes: Pedigree: AD30180_13
EXP: 5/9/2014
Pedigree: AD52378_1
EXP: 5/17/2014
Pedigree: W003356
EXP: 6/19/2014
Pedigree: W003526
EXP: 6/21/2014
Pedigree: AD39588_1
EXP: 5/13/2014.

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