Duloxetine Delayed-Release Capsules, USP, 60mg recall — FDA D-0583-2026
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
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The newest recall records with useful source details are listed here.
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
Presence of Foreign Substance:This recall has been initiated in response to a product quality complaint reported for black/brown specs and particles within the ampoule solution
Chemical Contamination: contamination with a diluted propylene glycol-based coolant from a machine leakage during the packaging process.
Failed Dissolution Specifications: An out-of-specification (OOS) result was observed during the 9th month of dissolution test analysis
Undeclared colors (Yellow #5, Yellow #6, and/or Red #40).
Premature lipid oxidation causing quality issue potentially causing product to have an off odor and bitter taste.
Undeclared colors (Yellow #5, Yellow #6, and/or Red #40).
Undeclared colors (Yellow #5, Yellow #6, and/or Red #40).
Undeclared colors (Yellow #5, Yellow #6, and/or Red #40).
Undeclared colors (Yellow #5, Yellow #6, and/or Red #40).
Undeclared colors (Yellow #5, Yellow #6, and/or Red #40).
Contains undeclared allergen (shrimp).
The ingredient, Pista, currently declared on our label should be corrected to the standard American nomenclature, Pistachio.
Undeclared colors (Yellow #5, Yellow #6, and/or Red #40).
Undeclared colors (Yellow #5, Yellow #6, and/or Red #40).
Undeclared colors (Yellow #5, Yellow #6, and/or Red #40).
Undeclared colors (Yellow #5, Yellow #6, and/or Red #40).
Undeclared colors (Yellow #5, Yellow #6, and/or Red #40).
Imported Enoki Mushrooms tested positive for Listeria Monocytogenes.
Undeclared colors (Yellow #5, Yellow #6, and/or Red #40).
Undeclared colors (Yellow #5, Yellow #6, and/or Red #40).
Undeclared colors (Yellow #5, Yellow #6, and/or Red #40).
Potential contamination with lead.
Undeclared FD&C Red 40
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