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CGMP Deviations: Firm did not adequately investigate customer complaints.
Failed Dissolution Specification; 6 month time point
Subpotent Drug: Low out-of-specification potency result of the drug product.
Failed Impurities/Degradation Specifications
Failed Dissolution Specifications: High out of specification dissolution result at 1 hour time point.
Labeling: Label Mix-Up; Bottles of Mucinex Fast-Max liquid are correctly labeled on the front of the label, however the back of the bottle where the Drug Facts labeling is, is missing certain Active Ingredients such as acetaminophen, phenylephrine, dextromethorphan, diphenhydramine, and/or guaifenesin. As a result certain safety warnings associated with those ingredients may also be missing.
Subpotent Drug: Flurandrenolide is subpotent.
Presence of Particulate Matter: The firm produced products using 0.9% Sodium Chloride Injection, USP or 5% Dextrose Injection, USP which were subsequently recalled by the manufacturer due to the presence of particulate matter.
Crystallization