Class II · Moderate risk
Dextroamphetamine Saccharate
Labeling: Label Error on Declared Strength; A sealed 100-count bottle labeled with 15 mg actually contained 100 tablets of 20 mg strength of the drug product.
FDA Drug Recalls
1,206 recalls · Class II, newest first
Class II · Moderate risk
QUAD-MIX 30MG/3MG/60MCG/0.2 Injectable
Lack of Assurance of Sterility
Class II · Moderate risk
QUAD-MIX 30/2/60/0.15 Injectable
Lack of Assurance of Sterility
Class II · Moderate risk
TRI-MIX 50/2.5/25 Injectable
Lack of Assurance of Sterility
Class II · Moderate risk
TRI-MIX 30/2/40 Injectable
Lack of Assurance of Sterility
Class II · Moderate risk
TRI-MIX 30/2/20 Injectable
Lack of Assurance of Sterility
Class II · Moderate risk
TRI-MIX 30/1/60 Injectable
Lack of Assurance of Sterility
Class II · Moderate risk
TRI-MIX 30/1/40 Injectable
Lack of Assurance of Sterility
Class II · Moderate risk
TRI-MIX 30/1/20 Injectable
Lack of Assurance of Sterility
Class II · Moderate risk
TRI-MIX 30/1/10 Injectable
Lack of Assurance of Sterility
Class II · Moderate risk
Test Cyp/Prop
Lack of Assurance of Sterility
Class II · Moderate risk
Test Cyp/Dhea
Lack of Assurance of Sterility
Class II · Moderate risk
Test Cyp/Dhea
Lack of Assurance of Sterility
Class II · Moderate risk
TEST CYP (Grapeseed)
Lack of Assurance of Sterility
Class II · Moderate risk
Semaglutide/Cyanocobalamin 24/2 MG/ML Injectable
Lack of Assurance of Sterility
Class II · Moderate risk
Semaglutide/Cyanocobalamin 10/2 MG/ML Injectable
Lack of Assurance of Sterility
Class II · Moderate risk
Semaglutide/Cyanocobalamin 5/2 MG/ML Injectable
Lack of Assurance of Sterility
Class II · Moderate risk
Sermorelin Acetate 1 MG/ML Injectable
Lack of Assurance of Sterility
Class II · Moderate risk
MIC/B12/L-Carn
Lack of Assurance of Sterility
Class II · Moderate risk
MIC/B12 25/50/50/1 MG/ML Injectable
Lack of Assurance of Sterility
Class II · Moderate risk
L-Carnitine 500 mg/mL Injectable
Lack of Assurance of Sterility
Class II · Moderate risk
Neomycin Sulfate Tablets
CGMP Deviations: A foreign matter identified as teflon was found in the Active Pharmaceutical Ingredient (API) used in the manufacture of Neomycin Sulfate Tablets, USP 500 mg.
Class II · Moderate risk
Difluprednate Ophthalmic Emulsion
Lack of Assurance of Sterility: customer complaint for defective container where breakage of the protective cap exposes tip of eye drop which could compromise sterility.
Class II · Moderate risk
Difluprednate Ophthalmic Emulsion
Lack of Assurance of Sterility: customer complaint for defective container where breakage of the protective cap exposes tip of eye drop which could compromise sterility.
Class II · Moderate risk
Triamcinolone Acetonide Cream USP
CGMP Deviations: Product complaints reporting the product to have a gritty texture and lack of effectiveness.