The Recall Desk
SevereFDA (Drugs)·D-1026-2014·Announced 2014-01-29

Aidapak Recalls Tri-Buffered Aspirin Tablets Due to Labeling Error

Aidapak Services is recalling Tri-Buffered Aspirin tablets because they may have been mislabeled as a different medication. The error involves a potential mix-up with Isometheptene Mucate/Dichlorphenazone/APAP capsules.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall is classified as FDA Class II, which corresponds to a severity score of 4 (Severe) according to the rubric, as it involves a labeling error that may cause temporary or medically reversible adverse health consequences.

Plain-English summary

Aidapak Services, LLC is recalling Tri-Buffered Aspirin, Tablet, 325 mg, Over The Counter (NDC 00904201559). The recall was initiated due to a labeling error where the product may have been mislabeled as Isometheptene Mucate/Dichlorphenazone/APAP, Capsule, 65 mg/100 mg/325 mg (NDC 44183044001). The affected Tri-Buffered Aspirin tablets have a pedigree of W003581 and an expiration date of 6/24/2014.

The repacked drugs were distributed in Arizona, California, Oregon, and Washington. The mislabeling could lead to patients receiving the wrong medication, which poses a risk of adverse health effects if the incorrect drug is taken. The FDA has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.

Consumers who have purchased this product should check their medication labels for the NDC 00904201559 and pedigree W003581. If the product matches these details, consumers should stop using it and contact their pharmacist or healthcare provider for guidance on proper disposal or replacement.

The recalled product

Product
TRI-BUFFERED ASPIRIN, Tablet, 325 mg, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 00904201559.
Affected units
100

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 (4)

  • TRI-BUFFERED ASPIRIN
  • Tablet
  • 325 mg has the following codes: Pedigree: W003581
  • EXP: 6/24/2014.

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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