Aidapak Recalls Omega-3 Fatty Acid Capsules Due to Labeling Error
Aidapak Services, LLC is recalling 2,799 Omega-3 Fatty Acid capsules because they may be mislabeled as Docusate Calcium. The error could lead to patients receiving the wrong medication.
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 is classified as FDA Class II, and the hazard involves a label mixup that could result in patients receiving the wrong medication, which is a risk-of-harm scenario where injury has not yet been reported.
Plain-English summary
Aidapak Services, LLC is voluntarily recalling 2,799 capsules of OMEGA-3 FATTY ACID, 1000 mg, Over The Counter. The recall is due to a labeling error where the product may be mislabeled as DOCUSATE CALCIUM, Capsule, 240 mg. The affected product is identified by NDC 00904404360.
The repacked drugs were distributed in Arizona, California, Oregon, and Washington. The recall involves specific pedigree codes and expiration dates ranging from May 2, 2014, to June 27, 2014. This labeling mixup poses a risk that patients may receive an incorrect medication, potentially leading to ineffective treatment or adverse health effects.
Consumers who have purchased this product should stop using it and contact their pharmacist or healthcare provider for guidance. They should check their medication bottles for the NDC 00904404360 and the specific pedigree codes listed in the recall notice to determine if they are affected.
The recalled product
- Product
- OMEGA-3 FATTY ACID, Capsule, 1000 mg, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 00904404360
- Manufacturer
- Aidapak Services, LLC
- Category
- Drug — Over-The-Counter
- Hazard
- Affected units
- 2,799
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 (20)
- OMEGA-3 FATTY ACID
- Capsule
- 1000 mg has the following codes: Pedigree: AD33897_19
- EXP: 5/9/2014
- Pedigree: AD32328_5
- Pedigree: W002852
- EXP: 6/7/2014
- Pedigree: AD62865_13
- EXP: 5/23/2014
- Pedigree: W002509
- EXP: 6/3/2014
- Pedigree: W003705
- EXP: 6/25/2014
- Pedigree: AD22845_7
- EXP: 5/2/2014
- Pedigree: AD39588_7
- EXP:5/13/2014
- Pedigree: AD73627_20
- EXP: 5/30/2014
- Pedigree: W003870
Distribution
Part of a larger recall action
This product is one of 273 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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