411 recalls · Class II, newest first
Reason cGMP Deviations: Out of specification results for micro in hand soap products.
Reason cGMP Deviations: Out of specification results for micro in hand soap products.
Reason cGMP Deviations: Out of specification results for micro in hand soap products.
Reason Lack of Sterility Assurance
Reason Marketed without an Approved NDA/ANDA: FDA analysis found product to be tainted with undeclared acetaminophen, diclofenac and phenylbutazone.
Reason cGMP Deviations: Presence of N-nitroso-Desmethyl-Diltiazem impurity above FDA recommended interim limit.
Reason cGMP Deviations: Presence of N-nitroso-Desmethyl-Diltiazem impurity above FDA recommended interim limit.
Reason cGMP Deviations: Presence of N-nitroso-Desmethyl-Diltiazem impurity above FDA recommended interim limit.
Reason cGMP Deviations: Presence of N-nitroso-Desmethyl-Diltiazem impurity above FDA recommended interim limit.
Reason cGMP Deviations: Presence of N-nitroso-Desmethyl-Diltiazem impurity above FDA recommended interim limit.
Reason cGMP Deviations: Presence of N-nitroso-Desmethyl-Diltiazem impurity above FDA recommended interim limit.
Reason cGMP Deviations
Reason Defective Delivery System: The product does not meet predetermined specifications for Coldflow (adhesive).
Reason Labeling: Missing Label
Reason Crystallization
Reason Defective Container: Unable to get the solution out of the bottle as the spike of the cap was lodged in the nozzle of the product bottle
Reason Failed Content Uniformity Specifications: Product failed to meet the action limits for stratified content uniformity.
Reason cGMP Deviations
Reason cGMP Deviations
Reason cGMP Deviations
Reason cGMP Deviations
Reason cGMP Deviations
Reason cGMP Deviations
Reason cGMP Deviations
Reason cGMP Deviations