Class II · Moderate risk
Omnipaque 240mg/mL PF
Lack of Assurance of Sterility
FDA Drug Recalls
11,818 recalls · Class II, newest first
Class II · Moderate risk
Lidocaine 1% PF
Lack of Assurance of Sterility
Class II · Moderate risk
Lidocaine/Dextrose 5%/7.5% PF
Lack of Assurance of Sterility
Class II · Moderate risk
Isovue 200 mg/mL PF and 300 mg/mL PF
Lack of Assurance of Sterility
Class II · Moderate risk
Hyaluronidase 150 u/ml PF
Lack of Assurance of Sterility
Class II · Moderate risk
Glycerin 100% PF
Lack of Assurance of Sterility
Class II · Moderate risk
Dexamethasone Sodium Phosphate 4 mg/mL vials PF
Lack of Assurance of Sterility
Class II · Moderate risk
Clonidine 100 mcg/mL PF
Lack of Assurance of Sterility
Class II · Moderate risk
Bupivacaine 0.25% PF
Lack of Assurance of Sterility
Class II · Moderate risk
Betamethasone Sodium Phosphate 6 mg/mL P Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Betamethasone Repository 6 mg/mL PF Injection and Betamethasone…
Lack of Assurance of Sterility
Class II · Moderate risk
Lactated Ringer's Injection USP
Chemical Contamination: The IV solutions were packaged in AVIVA containers which may contain trace levels of cumene hydroperoxide (CHP).
Class II · Moderate risk
0.9% Sodium Chloride Injection USP
Chemical Contamination: The IV solutions were packaged in AVIVA containers which may contain trace levels of cumene hydroperoxide (CHP).
Class II · Moderate risk
5% Dextrose and 0.45% Sodium Chloride Injection USP
Chemical Contamination: The IV solutions were packaged in AVIVA containers which may contain trace levels of cumene hydroperoxide (CHP).
Class II · Moderate risk
10% Dextrose Injection USP
Chemical Contamination: The IV solutions were packaged in AVIVA containers which may contain trace levels of cumene hydroperoxide (CHP).
Class II · Moderate risk
5% Dextrose Injection USP
Chemical Contamination: The IV solutions were packaged in AVIVA containers which may contain trace levels of cumene hydroperoxide (CHP).
Class II · Moderate risk
Limed Bone Gelatin
Microbial Contamination of Non-Sterile Products: Product is being recalled due to possible microbial contamination by C. difficile discovered in the raw material.
Class II · Moderate risk
Nutropin AQ NuSpin 10
Miscalibrated and/or Defective Delivery System: Genentech has received complaints for Nutropin AQ NuSpin 10 & 20 reporting that the dose knob spun slowly and the injection took longer than usual (slow dose delivery).
Class II · Moderate risk
Nutropin AQ NuSpin 20
Miscalibrated and/or Defective Delivery System: Genentech has received complaints for Nutropin AQ NuSpin 10 & 20 reporting that the dose knob spun slowly and the injection took longer than usual (slow dose delivery).
Class II · Moderate risk
UP & UP brand
Microbial Contamination of Non-Sterile Products: Laboratory findings of high total plate count above specification.
Class II · Moderate risk
UP & UP brand
Microbial Contamination of Non-Sterile Products: Laboratory findings of high total plate count above specification.
Class II · Moderate risk
Orajel Kids My Way! Anticavity Fluoride
CGMP Deviations: Product was made with an incorrect ingredient, Laureth-9 was mistakenly substituted for PEG.
Class II · Moderate risk
Cymevene 500 mg Powder for Infusion
Lack of Assurance of Sterility; container closure issues with the bulk batch.
Class II · Moderate risk
DRxChoice Fiber Capsules
Microbial Contamination of Non-Sterile Products: Product is being recalled due to possible microbial contamination by C. difficile discovered in the raw material.
Class II · Moderate risk
Premier Value Fiber Plus Calcium Supplement Capsules
Microbial Contamination of Non-Sterile Products: Product is being recalled due to possible microbial contamination by C. difficile discovered in the raw material.