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.
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 3/5 (High).
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.
- Manufacturer
- Aidapak Services, LLC
- 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
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.
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