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CGMP Deviations: recalling drug products following an FDA inspection.
Product may be contaminated with rodent hair and parts
Foreign Material (wood)
CGMP Deviations
Failed Dissolution Specifications: Out of specification dissolution results above specified values.
Product may be contaminated with foreign material
Lack of Assurance of Sterility: Potential presence of leaks originating from the Luer component.
Possible risk of pathogen contamination due to inadequate pasteurization.
CGMP Deviations: Discoloration
CGMP Deviations: Detection of N-nitroso-dabigatran (NDAB) impurity levels above the Acceptable Daily Intake Limit.
Peanuts are declared in the ingredients statement, but they are not declared in the allergen contains statement.