Class III · Low risk
Lumigan (bimatoprost ophthalmic solution)
Failed Impurities/Degradation Specifications
FDA drug recalls in 2017
Every FDA drug recall initiated in 2017, newest first, with its risk class, status and the reason the FDA recorded. Use the cause and risk filters to narrow the year down.
1,141 recalls, newest first.
Class III · Low risk
Fluphenazine Decanoate Injection
Subpotent Drug
Class II · Moderate risk
Divalproex Sodium Delayed Release Tablets
Failed Dissolution Specifications; 9 month long term stability
Class II · Moderate risk
Testosterone Cypionate Injection
Presence of Particulate Matter
Class II · Moderate risk
Sulfamethoxazole and Trimethoprim Oral Suspension
Failed Dissolution Specifications
Class II · Moderate risk
Cotellic (cobimetinib)
Superpotent Drug: An oversized tablet was found in a bottle.
Class I · High risk
EpiPen Jr. 2-Pak
Defective Delivery System; reports of the device failing to activate which could result in a patient not receiving medication
Class I · High risk
EpiPen 2-Pak
Defective Delivery System; reports of the device failing to activate which could result in a patient not receiving medication
Class II · Moderate risk
Metronidazole Injection
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
Levofloxacin Injection in 5% Dextrose
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
Fluconazole Injection
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
Ciprofloxacin in Dextrose
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
hydrALAZINE HYDROCHLORIDE INJECTION
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
Triamcinolone 40 mg/mL 2 mL Single-Dose Vial for Injection
CGMP Deviations
Class III · Low risk
Adalat CC (nifedipine)
Cross Contamination with another product:residual powder found in inlet air duct identified as sorafenib
Class III · Low risk
Adalat CC (nifedipine)
Cross Contamination with another product:residual powder found in inlet air duct identified as sorafenib
Class III · Low risk
Adalat CC (nifedipine)
Cross Contamination with another product:residual powder found in inlet air duct identified as sorafenib
Class III · Low risk
Adalat CC (nifedipine)
Cross Contamination with another product:residual powder found in inlet air duct identified as sorafenib
Class III · Low risk
Nifedipine Extended-Release Tablets
Cross Contamination with another product:residual powder found in inlet air duct identified as sorafenib
Class III · Low risk
Nifedipine Extended-Release Tablets
Cross Contamination with another product:residual powder found in inlet air duct identified as sorafenib
Class III · Low risk
Adalat CC (nifedipine)
Cross Contamination with another product:residual powder found in inlet air duct identified as sorafenib
Class III · Low risk
Adalat CC (nifedipine)
Cross Contamination with another product:residual powder found in inlet air duct identified as sorafenib
Class III · Low risk
Nifedipine Extended-Release Tablets
Cross Contamination with another product:residual powder found in inlet air duct identified as sorafenib
Class III · Low risk
Quillivant XR
Failed Dissolution Specifications: Dissolution at 8 hour was out of specification at 12 month at 25 degree Celsius.
Class III · Low risk
Quillivant XR
Failed Dissolution Specifications: Dissolution at 8 hour was out of specification at 12 month at 25 degree Celsius.