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Undeclared Allergen - Soy
CGMP Deviations: Out of Specification for Total Aerobic Microbial Count (TAMC) test for unfiltered bulk for decitabine for injection.
Mustard potato salad is being recalled due to plastic foreign material.
During an inspection by the SCDA the firm was notified that their label does not declare the allergen wheat.
Glazed ceramic plates are recalled because they may exceed FDA guidance levels for leachable lead (3.0mg/L).
Failed Impurities/Degradation Specifications: Product is being recalled due to API related substances and unknown impurities that are above the specification limits.
Failed Dissolution Specifications: results below specifications