Class III · Low risk Terminated
Isopto Carpine
Reason Failed Impurities/Degradation Specifications.
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Class II · Moderate risk Terminated
Atorvastatin Calcium Tablets
Reason Microbial Contamination of Non-Sterile Products: potential of an elevated bioburden with identification of objectionable organisms.
Class III · Low risk Terminated
CLENZIderm M.D. Acne Treatment System
Reason Discoloration.
Class III · Low risk Terminated
CLENZIderm M.D. Pore Therapy Salicylic Acid 2% Acne Treatment 5 fl. oz.
Reason Discoloration.
Class III · Low risk Terminated
Ciclopirox Olamine Cream USP
Reason Labeling: Incorrect or Missing Package Insert: product lots packaged with an out-of-date insert.
Class II · Moderate risk Terminated
Atorvastatin Calcium Tablets
Reason Microbial Contamination of Non-Sterile Products: potential of an elevated bioburden with identification of objectionable organisms.
Class II · Moderate risk Terminated
Atorvastatin Calcium Tablets
Reason Microbial Contamination of Non-Sterile Products: potential of an elevated bioburden with identification of objectionable organisms.
Class II · Moderate risk Terminated
Atorvastatin Calcium Tablets
Reason Microbial Contamination of Non-Sterile Products: potential of an elevated bioburden with identification of objectionable organisms.
Class II · Moderate risk Terminated
Atorvastatin Calcium Tablets
Reason Microbial Contamination of Non-Sterile Products: potential of an elevated bioburden with identification of objectionable organisms.
Class III · Low risk Terminated
Fluocinonide Cream UPS
Reason Cross contamination with other products: Certain lots of Fluocinonide Cream were found to be contaminated with a small quantity of hydrocortisone-17-valerate.
Class II · Moderate risk Terminated
Latanoprost Ophthalmic Solution
Reason Lack of assurance of sterility: product was found to be empty, under-filled, or leaking.
Class II · Moderate risk Terminated
Kalbitor
Reason Presence of Particulate Matter: Glass
Class III · Low risk Terminated
Lumigan
Reason Failed Impurities/Degradation Specifications
Class III · Low risk Terminated
Fluphenazine Decanoate Injection
Reason Subpotent Drug
Class II · Moderate risk Terminated
Divalproex Sodium Delayed Release Tablets
Reason Failed Dissolution Specifications; 9 month long term stability
Class II · Moderate risk Terminated
Testosterone Cypionate Injection
Reason Presence of Particulate Matter
Class II · Moderate risk Terminated
Sulfamethoxazole and Trimethoprim Oral Suspension
Reason Failed Dissolution Specifications
Class II · Moderate risk Terminated
Cotellic
Reason Superpotent Drug: An oversized tablet was found in a bottle.
Class II · Moderate risk Terminated
Metronidazole Injection
Reason Lack of Assurance of Sterility: there is potential of a leak from the primary container which may result in a potential breach of sterility and contamination of the product.
Class II · Moderate risk Terminated
Levofloxacin Injection in 5% Dextrose
Reason Lack of Assurance of Sterility: there is potential of a leak from the primary container which may result in a potential breach of sterility and contamination of the product.
Class II · Moderate risk Terminated
Fluconazole Injection
Reason Lack of Assurance of Sterility: there is potential of a leak from the primary container which may result in a potential breach of sterility and contamination of the product.
Class II · Moderate risk Terminated
Ciprofloxacin in Dextrose
Reason Lack of Assurance of Sterility: there is potential of a leak from the primary container which may result in a potential breach of sterility and contamination of the product.
Class II · Moderate risk Terminated
hydrALAZINE HYDROCHLORIDE INJECTION
Reason Temperature Abuse: Certain pieces of these lots distributed by McKesson Medical Surgical Inc. were inadvertently stored refrigerated rather than the labeled room temperature recommendation.
Class II · Moderate risk Terminated
Triamcinolone 40 mg/mL 2 mL Single-Dose Vial for Injection
Reason CGMP Deviations
Class III · Low risk Terminated
Adalat CC
Reason Cross Contamination with another product:residual powder found in inlet air duct identified as sorafenib