boardwalk ANTIBACTERIAL HANDSOAP REFILL, Chloroxylenol 0.1%, 1 gal. (3.78 L), Manufactured for Essendant Co., One Parkway North…
Reason cGMP Deviations: Out of specification results for micro in hand soap products.
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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 Failed Impurities/Degradation Specifications; during routine stability testing for impurities.
Reason Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and diclofenac.
Reason Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and diclofenac.
Reason Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and diclofenac.
Reason Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and diclofenac.
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 Failed Tablet/Capsule Specifications
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