All recalls7,877 total
CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
Elevated levels of lead 5.48mg/kg and 2.59mg/kg in (2) lots of Madras Curry Powder.
Mislabeled salads (undeclared peanut allergen). Incorrect ingredient applied (peanuts)
Microbial Contamination of Non-Sterile Products: Bacterial contamination with Staphylococcus aureus
Microbial Contamination of Non-Sterile Products: Bacterial contamination with Staphylococcus aureus
Microbial Contamination of Non-Sterile Products: Bacterial contamination with Staphylococcus aureus
Product contains elevated levels of lead - 6.50 mg/kg (ppm)
Undeclared Allergen - Milk
Product may be contaminated with foreign objects (white fragments of plastic, varying in length and width).
CGMP deviations: presence of N-Nitroso Carvedilol Impurity-1 (NNC 1), above the FDA recommended acceptable intake limit.
Failed Impurities/Degradation Specifications
Failed Impurities/Degradation Specifications
Foreign material appears to be white nylon or other plastic thread was found in product.
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.
Firm distributed a Seasoned Bread Crumb product with undeclared allergen (Sesame) not on the label.
Firm distributed a Bread Crumb product with undeclared allergen (Sesame) not on the label.
CGMP Deviations:N-Nitroso Carvedilol I impurity (NNCI-I) were found to be failing per current FDA recommended limit.
CGMP Deviations:N-Nitroso Carvedilol I impurity (NNCI-I) were found to be failing per current FDA recommended limit.
Contains undeclared visible almonds
Failed impurities/degradation specifications and Sub-potent Drug: Out-of-specification results were obtained during routine stability testing for Assay and Impurities.
Presence of Particulate Matter.
Failed impurities/degradation specifications and Sub-potent Drug: Out-of-specification results were obtained during routine stability testing for Assay and Impurities.
Out of Specification for Dissolution
Failed impurities/degradation specifications and Sub-potent Drug: Out-of-specification results were obtained during routine stability testing for Assay and Impurities.
Product may contain egg, an undeclared allergen.
Potato flour item #20501 was recalled due to undeclared milk (between 13ppm and 17ppm).
Regulatory documentation error and misleading color packaging claim.
Due to foreign object: metal balls (tiny non-magnetic metal balls measuring less than 2mm inside the gummies) intended for children
Due to potential Salmonella contamination
Labeling: Missing Label: The finished product potentially missing the labeling with the drug facts panel, bar code and directions for use.
cGMP Deviations: Product intended for quarantine was inadvertently distributed.
Undeclared allergen (Milk) in Shirakiku brand Curvee Puffs Corn Puff Snack
Undeclared allergen (Milk) in Shirakiku brand Curvee Puffs Corn Puff Snack
Undeclared allergen (Milk) in Shirakiku brand Curvee Puffs Corn Puff Snack
Failed Tablet/Capsule Specifications: Missing tab ID on either side of the tablet
Undeclared Red #3, Blue #1, Potassium Sorbate, and Propylene Glycol.