The Recall Desk
HighFDA (Drugs)·D-875-2014·Announced 2014-01-29

Aidapak Recalls Aspirin Tablets Due to Potential Label Mixup

Aidapak Services, LLC is recalling 81 mg Aspirin DR EC tablets because they may have been mislabeled as Sotalol HCl or Folic Acid.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a label mixup where a low-dose aspirin product could be mistaken for a prescription antiarrhythmic (Sotalol) or a vitamin. This presents a significant risk of incorrect medication administration, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Aidapak Services, LLC is recalling 1,499 tablets of ASPIRIN DR EC, 81 mg, Over The Counter (NDC 00182106105). The recall was initiated because the product may have been mislabeled as Sotalol HCl, 120 mg, or Folic Acid, 1 mg.

The affected repacked drugs were distributed in Arizona, California, Oregon, and Washington. The specific lots involved have pedigree codes AD52433_1 (expiration 5/17/2014) and W003094 (expiration 6/13/2014).

Consumers should check their medication for these specific NDC and pedigree codes. If the product matches the description, they should stop using it and contact their pharmacist or the recalling firm for instructions.

The recalled product

Product
ASPIRIN DR EC, Tablet, 81 mg, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 00182106105.
Affected units
1,499

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 (6)

  • ASPIRIN DR EC
  • Tablet
  • 81 mg has the following codes: Pedigree: AD52433_1
  • EXP: 5/17/2014
  • Pedigree: W003094
  • EXP: 6/13/2014.

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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