All recalls7,877 total
Presence of Particulate Matter: Potential for glass delamination from the vials.
cGMP Deviations: Observations were made that some blister card-foils were separating from the blister cavity.
cGMP Deviations: Observations were made that some blister card-foils were separating from the blister cavity.
Contains undeclared egg
Elevated Osmophilic Yeast Count
cGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit
Failed Impurity/Degradation Specifications
cGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit
Failed Impurity/Degradation Specifications
cGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit
Contains undeclared drugs Acetaminophen and Dexamethasone Phosphate, and the undeclared sweetener Aspartame
cGMP Deviations: Out of specification results for micro in hand soap products.
cGMP Deviations: Out of specification results for micro in hand soap products.
Lack of Sterility Assurance
cGMP Deviations: Out of specification results for micro in hand soap products.
cGMP Deviations: Out of specification results for micro in hand soap products.
cGMP Deviations: Out of specification results for micro in hand soap products.
Marketed without an Approved NDA/ANDA: FDA analysis found product to be tainted with undeclared acetaminophen, diclofenac and phenylbutazone.
cGMP Deviations: Out of specification results for micro in hand soap products.
Labeling Error. Nutren 2.0 UltraPak pouches were mislabeled with an Isosource 1.5 label.
Squash products potentially contaminated with Listeria monocytogenes.
Spreadable brie, 2/3lb used in sandwich was recalled by manufacturer due to possible Listeria monocytogenes contamination
Product does not include statement: Contains milk
Failed Impurities/Degradation Specifications; during routine stability testing for impurities.
Undeclared allergen labeling (milk)
Undeclared allergen labeling (milk)
Undeclared allergen labeling (milk)
The hermetic seal on the lid of the cans may be compromised
Undeclared allergen labeling (milk)
Undeclared eggs and yellow #5.
Contains undeclared soy lecithin
Undeclared allergen labeling (milk)
Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and diclofenac.
Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and diclofenac.
Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and diclofenac.
Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and diclofenac.
potential for pieces of metal in product
potential for pieces of metal in product
potential for pieces of metal in product
potential for pieces of metal in product
Products contain undeclared allergens (milk, soy, and wheat) and undeclared sulfites, yellow 5, yellow 6.
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).
Pieces of plastic in product
Salsa had pH of 4.7.
potential for pieces of metal in product
Pieces of plastic in product
Products contain undeclared allergens (milk, soy, peanut, and wheat) and undeclared sulfites, yellow 5, yellow 6, and red 40)