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.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. 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.
- Manufacturer
- Aidapak Services, LLC
- 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
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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