1,739 recalls · Class I, newest first
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.
Reason Failed Tablet/Capsule Specifications: Bottles shipped to the USA may contain empty capsules
Reason Failed Tablet/Capsule Specifications: Bottles shipped to the USA may contain empty capsules
Reason Labeling: Not Elsewhere Classified: misleading label similar in appearance to the FDA-approved drug product Adrenalin¿ (epinephrine injection, USP)
Reason Non-Sterility
Reason Marketed without an Approved NDA/ANDA; FDA laboratory analysis confirmed product tainted with undeclared metformin and glyburide
Reason Marketed without an Approved NDA/ANDA: FDA analysis found the products to be tainted with undeclared Furosemide, Dexamethasone and Chlorpheniramine
Reason Marketed without an approved NDA/ANDA. FDA analysis found the product to be tainted with Diclofenac and Dexamethasone.
Reason Labeling: Label Error on Declared Strength; Some cartons were incorrectly labeled. The blister strips inside the product carton reflect the correct…
Reason Labeling: Label Error on Declared Strength; Some cartons were incorrectly labeled. The blister strips inside the product carton reflect the correct…
Reason Labeling: Label Error on Declared Strength; Some cartons were incorrectly labeled. The blister strips inside the product carton reflect the correct…
Reason Labeling: Label Error on Declared Strength; Some cartons were incorrectly labeled. The blister strips inside the product carton reflect the correct…
Reason Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and diclofenac.
Reason Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and diclofenac.