45 recalls · Class I, newest first
Reason Marketed without approved NDA/ANDA- Laboratory analysis found product to be tainted with undeclared ingredients: Dexamethasone and Diclofenac.
Reason Marketed without approved NDA/ANDA- Laboratory analysis found product to be tainted with undeclared ingredients: Dexamethasone, Diclofenac and…
Reason Marketed without approved NDA/ANDA: The product has been found to be tainted with Sildenafil and Propoxyphenylsildenafil (a sildenafil analogue).
Reason Presence of Particulate Matter
Reason Marketed without an Approved NDA/ANDA: Laboratory analysis found the product to be tainted with undeclared propoxyphenylsildenafil and sildenafil.
Reason Marketed without an Approved NDA/ANDA: Laboratory analysis found the product to be tainted with undeclared propoxyphenylsildenafil and sildenafil.
Reason Marketed without an Approved NDA/ANDA: Laboratory analysis found the product to be tainted with undeclared chloropretadalafil…
Reason Marketed without an Approved NDA/ANDA: Laboratory analysis found the product to be tainted with undeclared propoxyphenylsildenafil and sildenafil.
Reason Marketed without an Approved NDA/ANDA: Laboratory analysis found the product to be tainted with undeclared propoxyphenylsildenafil and sildenafil.
Reason LABELING: LABEL MIX-UP: The infusion bag is incorrectly labeled as Levetiracetam in 0.82% Sodium Chloride Injection 500 mg/100 mL, while the aluminum…
Reason Marketed without an approved NDA/ANDA: Product found to be tainted with undeclared sildenafil and tadalafil.
Reason Presence of Particulate Matter
Reason Non-Sterility: contamination of Aspergillus penicillioides, due to breach in package lidding.
Reason Labeling: Label Error on Declared Strength. Overwrap labeled as Potassium Chloride Inj 10 mEq may contain flexible containers of Potassium Chloride…
Reason Labeling: Label Error on Declared Strength. Cases labeled POTASSIUM CHLORIDE 20 mEq, may contain flexible containers with overwrap mislabeled as 10…
Reason Defective delivery system - patches could be multi-stacked, adhered one on top of the other, in a single product pouch.
Reason Microbial Contamination of Non-Sterile Products: Bacterial contamination with Staphylococcus aureus
Reason Microbial Contamination of Non-Sterile Products: Bacterial contamination with Staphylococcus aureus
Reason Microbial Contamination of Non-Sterile Products: Bacterial contamination with Staphylococcus aureus
Reason Presence of Particulate Matter.