Class II · Moderate risk Terminated
NORepinephrine Bitartrate 0.9% Sodium Chloride Injection USP
Reason cGMP violations
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Class II · Moderate risk Terminated
Vancomycin HCl 750 mg per 250 mL 0.9% Sodium Chloride Injection USP
Reason cGMP violations
Class II · Moderate risk Terminated
Phenylephrine HCl 0.9% Sodium Chloride Injection USP
Reason cGMP violations
Class II · Moderate risk Terminated
Phenylephrine HCl 0.9% Sodium Chloride Injection USP
Reason cGMP violations
Class II · Moderate risk Terminated
Phenylephrine HCl 0.9% Sodium Chloride Injection USP
Reason cGMP violations
Class II · Moderate risk Terminated
Phenylephrine HCl 0.9% Sodium Chloride Injection USP
Reason CGMP violations
Class II · Moderate risk Ongoing
Dapsone Gel 7.5%
Reason Crystallization
Class II · Moderate risk Ongoing
Ryaltris
Reason Defective Delivery System: The dip tube is clogged causing the spray not to work.
Class II · Moderate risk Terminated
Atorvastatin Calcium Tablets
Reason 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.
Class II · Moderate risk Ongoing
Pluvicto
Reason CGMP deviations
Class I · High risk Terminated
Veklury
Reason Presence of Particulate Matter: Presence of glass particle.
Class II · Moderate risk Ongoing
EnviroClean Hand Sanitizer Gel
Reason CGMP deviations
Class I · High risk Ongoing
Vail-Bon Jie Yang Wan capsules
Reason Marketed without an approved NDA/ANDA: Product found to be tainted with undeclared dexamethasone and chlorpheniramine.
Class I · High risk Terminated
Atovaquone Oral Suspension
Reason Microbial Contamination of a Non-sterile Product: The product was found to be contaminated with Cohnella bacteria.
Class II · Moderate risk Ongoing
Refresh LACRI-LUBE
Reason Lack of Assurance of Sterility: The impacted lots may contain a breach in the tube seal.
Class II · Moderate risk Ongoing
Refresh P.M.
Reason Lack of Assurance of Sterility: The impacted lots may contain a breach in the tube seal.
Class II · Moderate risk Terminated
Proparacaine Hydrochloride Ophthalmic Solution
Reason Temperature abuse: Products exposed to improper temperature above drug label specifications.
Class II · Moderate risk Terminated
Hylenex recombinant
Reason cGMP Deviations: Temperature excursion
Class II · Moderate risk Ongoing
First Aid Antiseptic Ointment
Reason 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.
Class II · Moderate risk Terminated
Pyridoxine HCL
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
Mycophenolic Acid Delayed-Release Tablets USP
Reason Failed Dissolution Specifications
Class II · Moderate risk Ongoing
Vivier Sheer SPF 30 Mineral With Antioxidants
Reason Microbial Contamination of Non-Sterile Product
Class II · Moderate risk Completed
Mupirocin Ointment
Reason Subpotent Drug
Class II · Moderate risk Ongoing
Barrier Therapy Skin Protectant Cream
Reason Microbial contamination of non-sterile Products -
Class III · Low risk Ongoing
AcetaZOLAMIDE Tablets
Reason Discoloration