23 FDA recalls mention Omega. The most recent are listed below.
Recalls are matched by product description. A recall usually affects specific lots, not every package of Omega.
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…
Reason Marketed Without An Approved NDA/ANDA: FDA laboratory analysis found the product to contain undeclared diclofenac and dexamethasone.
Reason Marketed Without An Approved NDA/ANDA: FDA laboratory analysis found the product to contain undeclared diclofenac.
Reason Marketed Without An Approved NDA/ANDA: FDA laboratory analysis found the product to contain undeclared diclofenac.
Reason Marketed Without An Approved NDA/ANDA: FDA laboratory analysis found the product to contain undeclared diclofenac.
Reason Marketed Without An Unapproved NDA/ANDA: All lots were found to be unapproved drugs based on labeling claims.
Reason Marketed Without An Unapproved NDA/ANDA: All lots were found to be unapproved drugs based on labeling claims.
Reason Marketed Without An Unapproved NDA/ANDA: Product lot found to be tainted with undeclared diclofenac, an FDA approved nonsteroidal anti-inflammatory…
Reason CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Reason API material used in the manufacturing of the product did not receive regulatory approval prior to release.
Reason Labeling: Label Mixup: OMEGA-3-ACID ETHYL ESTERS, Capsule, 1000 mg may have potentially been mislabeled as one of the following drugs: SEVELAMER…
Reason Labeling: Label Mixup; OMEGA-3 FATTY ACID Capsule, 1000 mg may be potentially mislabeled as PYRIDOXINE HCL, Tablet, 50 mg, NDC 00904052060…
Reason Labeling: Label Mixup; OMEGA-3 FATTY ACID, Capsule, 1000 mg may be potentially mislabeled as tiZANidine HCL, Tablet, 2 mg, NDC 57664050289…
Reason Labeling: Label Mixup; OMEGA-3 FATTY ACID, Capsule, 1000 mg may be potentially mislabeled as NORTRIPTYLINE HCL, Capsule, 50 mg, NDC 00093081201…
Reason Labeling: Label Mixup; OMEGA-3 FATTY ACID, Capsule, 1000 mg may be potentially mis-labeled as DOCUSATE CALCIUM, Capsule, 240 mg, NDC 00536375501…
Reason Subpotent; Beta carotene (Vitamin A)
Reason Subpotent; Beta carotene (Vitamin A)
Reason Subpotent; Beta carotene (Vitamin A)
Reason Subpotent; Beta carotene (Vitamin A)
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