Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Labeling: Label Mixup; OMEGA-3 FATTY ACID Capsule, 1000 mg may be potentially mislabeled as PYRIDOXINE HCL, Tablet, 50 mg, NDC 00904052060, Pedigree: AD22865_19, EXP: 5/2/2014; CHOLECALCIFEROL, Capsule, 2000 units, NDC 00536379001, Pedigree: AD30028_7, EXP: 5/8/2014; DOCUSATE SODIUM, Capsule, 250 mg, NDC 00536375710, Pedigree: W003054, EXP: 6/12/2014; CHOLECALCIFEROL, Capsule, 2000 units, ND
OMEGA-3 FATTY ACID Capsule, 1000 mg, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 40985022921
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
Reason Failed Capsule Specifications: Out of specification results obtained during routine stability testing for Loss on Drying of Capsule Shells.
Reason Marketed without an Approved NDA/ANDA: FDA analysis found the product to be tainted with undeclared diclofenac and acetaminophen.
Reason Marketed Without an Approved NDA/ANDA: products found to contain undeclared diclofenac.
Reason Sub Potent and Super Potent Product: During an impact assessment of the DOP Hand Sanitizer product, it was identified that several lots distributed…
Reason Sub Potent and Super Potent Product: During an impact assessment of the DOP Hand Sanitizer product, it was identified that several lots distributed…
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