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).
FDA drug recalls in 2012
Every FDA drug recall initiated in 2012, newest first, with its risk class, status and the reason the FDA recorded. Use the cause and risk filters to narrow the year down.
534 recalls, newest first.
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 I · High risk
Hydrocodone Bitartrate and Acetaminophen Tablets USP
Superpotent (Multiple Ingredient) Drug: There is the potential for oversized and superpotent tablets.
Class I · High risk
SLIM XTREME Herbal Slimming Capsule
Marketed Without an Approved NDA/ANDA: Product tested positive for Sibutramine, an appetite suppressant that was withdrawn from the U.S. market in October 2010 for safety reasons, making this product an unapproved new drug.
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 III · Low risk
Children's Cetirizine HCl Chewable Tablets 5 mg
Impurity/Degradation; exceeded impurity specification at the 8 and 15 month time points (betacyclodextrin ester 1&2)
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 III · Low risk
Pramipexole Dihydrochloride Tablets
Impurities/Degradation Products: An out of specification result for a known impurity of the product occurred during 12 month stability testing.
Class III · Low risk
Pramipexole Dihydrochloride Tablets
Impurities/Degradation Products: An out of specification result for a known impurity of the product occurred during 12 month stability testing.
Class I · High risk
HYDROCODONE BITARTRATE and ACETAMINOPHEN TABLETS
Superpotent (Multiple Ingredient) Drug: Confirmed customer complaints of oversized tablets resulting in superpotent assays of both the hydrocodone and acetaminophen components.
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 III · Low risk
Enalapril Maleate Tablet
Labeling Illegible: Some bottles labels have incomplete NDC numbers and missing strength.
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.
Class II · Moderate risk
Premier Value 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
Simply Right Healthcare 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
Berkley & Jensen 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
Wal-Mucil Plus Calcium 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
Wal-Mucil 100% Natural Fiber
Microbial Contamination of Non-Sterile Products: Product is being recalled due to possible microbial contamination by C. difficile discovered in the raw material.