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Products contain elevated levels of Lead (Pb): 3.231 ppm and Arsenic (As): 0.958 ppm;
Products contain elevated levels of Lead (Pb): 3.688 ppm
Products contain elevated levels of Lead (Pb): 88.038 ppm
The devices are missing the laser marked depth markings.
Identified curing issues with the silicone during the needles manufacturing process.
CGMP deviations: The presence of nitrosamine impurity above the acceptable daily intake limits.
Super-Potent Drug: Out of specification potency results were obtained.
CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit.
Defective Container: blister packs not properly sealed resulting in tablets being loose in the carton.
Lack of Assurance of Sterility
Labeling; Label Mixup; some bottles have an incorrect back label indicating 91% Isopropyl Alcohol
The battery for certain ultrasound systems can potentially develop an internal failure which could result in smoke or fire.
The incorrect value of the International Sensitivity Index (ISI) is printed on the outer box label.