Class II · Moderate risk
Energique
Microbial Contamination of Non Sterile Products; testing revealed out of specification results for total aerobic microbiological count
Class II drug recalls - moderate risk
Class II means the product may cause temporary or medically reversible harm, and serious harm is unlikely. It is by far the largest recall class - most potency, dissolution and labeling problems land here.
14,543 recalls, newest first.
Class II · Moderate risk
Energique
Microbial Contamination of Non Sterile Products; testing revealed out of specification results for total aerobic microbiological count
Class II · Moderate risk
Energique
Microbial Contamination of Non Sterile Products; testing revealed out of specification results for total aerobic microbiological count
Class II · Moderate risk
Energique
Microbial Contamination of Non Sterile Products; testing revealed out of specification results for total aerobic microbiological count
Class II · Moderate risk
Energique
Microbial Contamination of Non Sterile Products; testing revealed out of specification results for total aerobic microbiological count
Class II · Moderate risk
Daytrana (methylphenidate transdermal system)
Defective Delivery System: Out of Specification (OOS) results for the mechanical peel force (MPF) and z-statistic value which relates to the patients and caregiver ability to remove the release liner from the patch adhesive prior to administration.
Class II · Moderate risk
Daytrana (methylphenidate transdermal system)
Defective Delivery System: Out of Specification (OOS) results for the mechanical peel force (MPF) and z-statistic value which relates to the patients and caregiver ability to remove the release liner from the patch adhesive prior to administration.
Class II · Moderate risk
Daytrana (methylphenidate transdermal system)
Defective Delivery System: Out of Specification (OOS) results for the mechanical peel force (MPF) and z-statistic value which relates to the patients and caregiver ability to remove the release liner from the patch adhesive prior to administration.
Class II · Moderate risk
Capecitabine tablets USP 500 mg
Failed Dissolution Specifications: low test results at the 18 month time-point
Class II · Moderate risk
Ventolin HFA
Defective Delivery System: Some canisters may not contain sufficient propellant to deliver the labeled claim of 200 actuations through the end of shelf life.
Class II · Moderate risk
Oxygen
cGMP Deviations; trailer may not have met GMP requirements prior to filling
Class II · Moderate risk
Dextroamphetamine Saccharate
Failed Impurities/Degradation Specifications: High out of specification test result for impurities during stability testing.
Class II · Moderate risk
tubby todd Bath Co
Microbial Contamination of Non-Sterile Products: Consumer complaint and subsequent testing found lot to be out of specification for mold.
Class II · Moderate risk
SyrSpend SF
Microbial Contamination of Non-Sterile Products: Syrspend SF and Syrspend SF Grape Flavor are being recalled due to the presence of yeast.
Class II · Moderate risk
SyrSpend SF
Microbial Contamination of Non-Sterile Products: Syrspend SF and Syrspend SF Grape Flavor are being recalled due to the presence of yeast.
Class II · Moderate risk
SyrSpend SF
Microbial Contamination of Non-Sterile Products: Syrspend SF and Syrspend SF Grape Flavor are being recalled due to the presence of yeast.
Class II · Moderate risk
Rocuronium Bromide 50 MG/5ML INJ.
Labeling: Incorrect Instructions; RemedyRepack, Inc. a relabeler, is recalling these products due to incorrect storage instructions.
Class II · Moderate risk
Novolin 70/30
Labeling: Incorrect Instructions; RemedyRepack, Inc. a relabeler, is recalling these products due to incorrect storage instructions.
Class II · Moderate risk
Lorazepam 2 mg/mL Inj.
Labeling: Incorrect Instructions; RemedyRepack, Inc. a relabeler, is recalling these products due to incorrect storage instructions.
Class II · Moderate risk
Ascorbic Acid 500 MG/ML Inj.
Labeling: Incorrect Instructions; RemedyRepack, Inc. a relabeler, is recalling these products due to incorrect storage instructions.
Class II · Moderate risk
Vitamin B-Complex 100
Labeling: Incorrect Instructions; RemedyRepack, Inc. a relabeler, is recalling these products due to incorrect storage instructions.
Class II · Moderate risk
Bicillin L-A 600000 Units/mL Inj.
Labeling: Incorrect Instructions; RemedyRepack, Inc. a relabeler, is recalling these products due to incorrect storage instructions.
Class II · Moderate risk
Humulin 70/30
Labeling: Incorrect Instructions; RemedyRepack, Inc. a relabeler, is recalling these products due to incorrect storage instructions.
Class II · Moderate risk
3-in-1 TPN formula daily+overfill Bag
Lack of Assurance of Sterility
Class II · Moderate risk
0.9% Sodium Chloride/MVI injection 2000 mL Bag
Lack of Assurance of Sterility