Omega-3 Fatty Acid Capsules Recalled for Potential Labeling Error
Aidapak Services is recalling 1000 mg Omega-3 Fatty Acid capsules because they may be mislabeled as Nortriptyline HCL 50 mg.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II and involves a labeling error (mislabeling) without reported injuries or illnesses, fitting the criteria for moderate severity.
Plain-English summary
Aidapak Services, LLC is recalling 90-count bottles of OMEGA-3 FATTY ACID, Capsule, 1000 mg, Over The Counter, NDC 05445800022. The recall is due to a labeling error where the product may be mislabeled as NORTRIPTYLINE HCL, Capsule, 50 mg, NDC 00093081201.
The affected product has the pedigree AD21858_4 and an expiration date of 5/1/2014. The repacked drugs were distributed in Arizona, California, Oregon, and Washington.
Consumers should check their medication labels and discontinue use if the product matches the description above. They should contact their pharmacist or healthcare provider for guidance on proper medication management.
The recalled product
- Product
- OMEGA-3 FATTY ACID, Capsule, 1000 mg, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 05445800022
- Manufacturer
- Aidapak Services, LLC
- Hazard
- Affected units
- 90
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)
- OMEGA-3 FATTY ACID
- Capsule
- 1000 mg has the following code Pedigree: AD21858_4
- EXP: 5/1/2014.
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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