Agency classClass IIOur severity:Moderate FDA (Drugs)·D-926-2014·Announced 2014-01-29

Aidapak Recalls Acetaminophen Chew Tablets Due to Labeling Mixup

Aidapak Services, LLC is recalling Acetaminophen chew 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 and involves a labeling error (mislabeling) without reported injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.

Plain-English summary

Aidapak Services, LLC is voluntarily recalling Acetaminophen, Chew Tablet, 80 mg, Over The Counter, NDC 00536323307. The recall is due to a labeling mixup where the product may have been mislabeled as other drugs, including Benazepril HCL, Ascorbic Acid, Omega-3 Fatty Acid, or Tacrolimus.

The affected product consists of 120 chew tablets. The repacked drugs were distributed in Arizona, California, Oregon, and Washington. Specific pedigree codes and expiration dates are associated with the recalled lots.

Consumers who have this product should stop using it and contact their pharmacist or the recalling firm for instructions on how to return or dispose of the medication. This recall is classified as FDA Class II, indicating a reasonable probability of temporary or medically reversible adverse health consequences.

The recalled product

Product: ACETAMINOPHEN, CHEW Tablet, 80 mg, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 00536323307.
Manufacturer: Aidapak Services, LLC
Category: Drug — Over-the-Counter Medication
Hazard: mis-labeling
Affected units: 120

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 (10)

ACETAMINOPHEN
CHEW Tablet
80 mg has the following codes: Pedigree: AD49399_1
EXP: 5/16/2014
Pedigree: W003113
EXP: 6/13/2014
Pedigree: AD30180_7
EXP: 5/8/2014
Pedigree: W003050
EXP: 6/12/2014.

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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