Handsome Brook Farms Kirkland Signature ORGANIC EGGS PASTURE-RAISED 24 EGGS, GRADE recall — FDA F-0314-2025
Eggs from a positive Salmonella environment were shipped into distribution to retail facilities.
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Eggs from a positive Salmonella environment were shipped into distribution to retail facilities.
Product contains undeclared fish (anchovy) and soy.
CGMP Deviations: presence of N-nitroso-duloxetine impurity above FDA recommended interim limit.
cGMP Deviations: the firm initiated a recall after notification from the distributor that product may be tainted with undeclared diclofenac and omeprazole, however there is no analytical…
CGMP Deviations: the presence of a Nitrosamine Drug Substance Related Impurity (NDSRI), N-Nitroso-Duloxetine above the interim acceptable intake limit
CGMP Deviations; presence of N-nitroso-duloxetine impurity above recommended interim limit.
Lack of Assurance of Sterility; Improper crimps on vials impacting the integrity of the product
CGMP Deviations: presence of N-nitroso-duloxetine impurity above FDA recommended interim limit.
Foreign Material (metal)
Possible contamination by a foreign object (metal) in sub-ingredient in dinner roll product
Potential for contamination of Listeria monocytogenes. Environmental sample collected by FDA yielded positive results for one Zone 1 (cutting board) and one Zone 3 (floor drain).
foreign material
Possible contamination by a foreign object (metal) in sub-ingredient in dinner roll product
potential for salmonella
The firm was notified by the Texas Department of Agriculture that the product test positive for Listeria monocytogenes.
CGMP deviations: the bulk product was rejected by the Quality Unit after routine inspection of the mixing vessel showed scratches on the sides and bottom of the mixing vessel. Product was…
CGMP deviations: the bulk product was rejected by the Quality Unit after routine inspection of the mixing vessel showed scratches on the sides and bottom of the mixing vessel. Product was…
Failed Impurities/Degradation Specifications
CGMP deviations: the bulk product was rejected by the Quality Unit after routine inspection of the mixing vessel showed scratches on the sides and bottom of the mixing vessel. Product was…
CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-Nitroso Nebivolol above acceptable intake (AI) limit.
CGMP deviations: the bulk product was rejected by the Quality Unit after routine inspection of the mixing vessel showed scratches on the sides and bottom of the mixing vessel. Product was…
CGMP deviations: out of specifications for assay
CGMP deviations: the bulk product was rejected by the Quality Unit after routine inspection of the mixing vessel showed scratches on the sides and bottom of the mixing vessel. Product was…
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