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cGMP violations
CGMP violations
Crystallization
Presence of Foreign Tablets/Capsules: A Carbamazepine Extended-Release 400 mg tablet was found in a 1000-count bottle of Atorvastatin Calcium Tablets, USP 40 mg.
Presence of Particulate Matter: Presence of glass particle.
Marketed without an approved NDA/ANDA: Product found to be tainted with undeclared dexamethasone and chlorpheniramine.
Microbial Contamination of a Non-sterile Product: The product was found to be contaminated with Cohnella bacteria.
Lack of Assurance of Sterility: The impacted lots may contain a breach in the tube seal.
Temperature abuse: Products exposed to improper temperature above drug label specifications.
Incorrect/Undeclared Excipients: The inactive ingredients labeled on the product boxes and tubes are listed as "mineral oil , petrolatum ". The inactive ingredients in the actual product are polyethylene glycol 400 , polyethylene glycol 4000.
cGMP Deviations: Temperature excursion
Product was recalled due to the potential for contamination with Salmonella
Lack of Assurance of Sterility
Failed Dissolution Specifications
Subpotent Drug