All recalls7,877 total
Products contain elevated levels of Lead (Pb): 6.504 ppm
Products contain elevated levels of Lead (Pb): 88.038 ppm
Labeling; Label Mixup; some bottles have an incorrect back label indicating 91% Isopropyl Alcohol
Lack of Assurance of Sterility
Super-Potent Drug: Out of specification potency results were obtained.
CGMP deviations: The presence of nitrosamine impurity above the acceptable daily intake limits.
CGMP deviations: The presence of nitrosamine impurity above the acceptable daily intake limits.
Super-Potent Drug: Out of specification potency results were obtained.
Defective Container: blister packs not properly sealed resulting in tablets being loose in the carton.
CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit.
CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit.
Foreign object (plastic)
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Contains undeclared and unallowed colors (Blue 1, Red 40, Acid Red 18)
Contains undeclared and unallowed colors (Blue 1, Red 40, Acid Red 18)
Presence of foreign substance: Presence of Benzene.
Failed Dissolution Specifications
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above recommended interim limit.
Presence of foreign substance: Presence of Benzene.
cGMP Deviations: The recall was initiated due to detected trace levels of benzene in a specific lot of this product lot (MYX46W), however out of an abundance of caution, the firm voluntarily recalled all La Roche-Posay Effaclar Duo Dual Action Acne Treatment lots.
cGMP Deviations: The recall was initiated due to detected trace levels of benzene in a specific lot of this product lot (MYX46W), however out of an abundance of caution, the firm voluntarily recalled all La Roche-Posay Effaclar Duo Dual Action Acne Treatment lots.
Chemical Contamination: This recall has been initiated due to detected trace levels of benzene.
(Imported) Hot Pot Sauce contains undeclared allergens (Wheat and Soy)
(Imported) Hot Pot Sauce (SPICY) contains undeclared allergens (Wheat and Soy)
Label declares tofu but it does not declare soy.
Undeclared allergen (milk)
Undeclared allergen (milk)
Undeclared allergen (milk)
Product contains cyclamates
CGMP Deviations: Nitrosamine Drug Substance Related Issue impurity above the daily acceptable intake limit defined by the Food and Drug Administration.
Failed Dissolution Specifications: Out of specification results obtained during routine stability testing for dissolution.
Product may contain incorrect salad dressing, resulting in fish and wheat being undeclared.
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit.
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit.
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit.
Chemical Contamination: Presence of benzene
CGMP Deviations; presence 'N-Nitroso Carvedilol I' Impurity above the recommended acceptable intake limit
CGMP Deviations; presence 'N-Nitroso Carvedilol I' Impurity above the recommended acceptable intake limit
CGMP Deviations; presence 'N-Nitroso Carvedilol I' Impurity above the recommended acceptable intake limit
CGMP Deviations; presence 'N-Nitroso Carvedilol I' Impurity above the recommended acceptable intake limit
Product contains higher sodium amount than stated on label
Stability data does not support expiry: the products have the potential to be out of specification at the time of expiry of 36-months.
Stability data does not support expiry: the products have the potential to be out of specification at the time of expiry of 36-months.
Beckman Coulter has received complaints of erroneous Vitamin B12 results when using Access Vitamin B12 Reagent lot 439850. The affected reagent lot may cause erroneously low or high Vitamin B12 results, leading to a delayed or improper diagnosis and/or repeat testing.