Class III · Low risk Terminated
Norpace CR
Reason Failed Dissolution Specification
FDA Drug Recalls
14,801 recalls, newest first
Class II · Moderate risk Terminated
Oxygen
Reason cGMP Deviations; trailer may not have met GMP requirements prior to filling
Class III · Low risk Terminated
Meclizine Hydrochloride Tablets
Reason Failed Impurities/Degradation Specifications: Out of specification for impurities.
Class III · Low risk Terminated
Meclizine Hydrochloride Tablets
Reason Failed Impurities/Degradation Specifications: Out of specification for impurities.
Class I · High risk Terminated
SUPER HERBS 350 mg
Reason Marketed without an approved NDA/ANDA - presence of undeclared sibutramine, desmethylsibutramine (an active metabolite of sibutramine) and/or phenolphthalein.
Class III · Low risk Terminated
NABUMETONE Tablets USP
Reason Labeling: Not Elsewhere Classified: Lack of leaflets and approved labels on bottles.
Class II · Moderate risk Terminated
Dextroamphetamine Saccharate
Reason Failed Impurities/Degradation Specifications: High out of specification test result for impurities during stability testing.
Class II · Moderate risk Terminated
tubby todd Bath Co
Reason Microbial Contamination of Non-Sterile Products: Consumer complaint and subsequent testing found lot to be out of specification for mold.
Class II · Moderate risk Terminated
SyrSpend SF
Reason 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 Terminated
SyrSpend SF
Reason 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 Terminated
SyrSpend SF
Reason 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 Terminated
Rocuronium Bromide 50 MG/5ML INJ.
Reason Labeling: Incorrect Instructions; RemedyRepack, Inc. a relabeler, is recalling these products due to incorrect storage instructions.
Class II · Moderate risk Terminated
Novolin 70/30
Reason Labeling: Incorrect Instructions; RemedyRepack, Inc. a relabeler, is recalling these products due to incorrect storage instructions.
Class II · Moderate risk Terminated
Lorazepam 2 mg/mL Inj.
Reason Labeling: Incorrect Instructions; RemedyRepack, Inc. a relabeler, is recalling these products due to incorrect storage instructions.
Class II · Moderate risk Terminated
Ascorbic Acid 500 MG/ML Inj.
Reason Labeling: Incorrect Instructions; RemedyRepack, Inc. a relabeler, is recalling these products due to incorrect storage instructions.
Class II · Moderate risk Terminated
Vitamin B-Complex 100
Reason Labeling: Incorrect Instructions; RemedyRepack, Inc. a relabeler, is recalling these products due to incorrect storage instructions.
Class II · Moderate risk Terminated
Bicillin L-A 600000 Units/mL Inj.
Reason Labeling: Incorrect Instructions; RemedyRepack, Inc. a relabeler, is recalling these products due to incorrect storage instructions.
Class II · Moderate risk Terminated
Humulin 70/30
Reason Labeling: Incorrect Instructions; RemedyRepack, Inc. a relabeler, is recalling these products due to incorrect storage instructions.
Class II · Moderate risk Terminated
3-in-1 TPN formula daily+overfill Bag
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
0.9% Sodium Chloride/MVI injection 2000 mL Bag
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
0.9% Sodium Chloride injection bag
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Dextrose 5% and 0.9% Sodium Chloride injection bag a) 1000 mL
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Cefepime 1 g/NS 100 mL Minibag Plus
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Tobramycin 620 mg/NS 100 mL Accuflo
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Remicade
Reason Lack of Assurance of Sterility