All recalls8,521 total
Product's easy-pull lid was not secured properly and may cause the product to become adulterated with the hazard clostridium botulinum.
Product's easy-pull lid was not secured properly and may cause the product to become adulterated with the hazard clostridium botulinum.
Product's easy-pull lid was not secured properly and may cause the product to become adulterated with the hazard clostridium botulinum.
Product's easy-pull lid was not secured properly and may cause the product to become adulterated with the hazard clostridium botulinum.
Product's easy-pull lid was not secured properly and may cause the product to become adulterated with the hazard clostridium botulinum.
Product's easy-pull lid was not secured properly and may cause the product to become adulterated with the hazard clostridium botulinum.
Product's easy-pull lid was not secured properly and may cause the product to become adulterated with the hazard clostridium botulinum.
Subpotent Drug: Out of Specification (OOS) result for De hydro Impurity (0.654%) for 18 M Stability sample and low assay 94.9% (specification of NLT 95.0% NMT 105%)
Multiple complaints indicating lower than expected quality control (QC) results and in some instances QC recovery below the lower limit of the package insert acceptance range when testing is performed with HemosIL Liquid Anti-Xa and HemosIL Heparin Calibrator. In some complaints, failure to pass QC resulted in patient testing delays.
Product tested positive for Salmonella
Firm received complaints of infant choking.
Undeclared Yellow #5
Firm received complaints of infant choking.
Lack of Assurance of Sterility
Defective delivery system - patches could be multi-stacked, adhered one on top of the other, in a single product pouch.
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
Failed Dissolution Specifications.
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.
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