Class I · High risk Ongoing
Optiray Imaging Bulk Package-350
Reason Presence of Particulate Matter: comprising polyethylene and other plastic materials, stainless steel and glass.
FDA Drug Recalls
220 recalls · Class I, newest first
Class I · High risk Ongoing
Cyclophosphamide for Injection
Reason Presence of Particulate Matter; identified as stainless steel
Class I · High risk Ongoing
Cyclophosphamide for Injection
Reason Presence of Particulate Matter; identified as stainless steel
Class I · High risk Ongoing
Glutathione
Reason Microbial Contamination of Sterile Products - out of specifications results were obtained for bacterial endotoxin.
Class I · High risk Ongoing
Cetirizine Hydrochloride Tablets USP 5 mg
Reason Cross Contamination with Other Products: Customer complaints for appearance of discolored tablets and red dots observed on Cetirizine Hydrochloride Tablets USP 5 mg. Determined to be Ranitidine.
Class I · High risk Ongoing
Gas-X Extra Strength
Reason Chemical Contamination: contamination with a diluted propylene glycol-based coolant from a machine leakage during the packaging process.
Class I · High risk Ongoing
BEEKEEPER'S NATURALS Saline Nasal Spray
Reason Microbial Contamination of Non-Sterile Products
Class I · High risk Ongoing
BD ChloraPrep FREPP Clear
Reason Non-Sterility: Due to presence of Aspergillus penicillioides. And Lack of Assurance of Sterility: Due to wrinkles in the paper lidding which may breach the seal area.
Class I · High risk Ongoing
BD ChloraPrep Clear
Reason Non-Sterility: Due to presence of Aspergillus penicillioides.
Class I · High risk Ongoing
DOXOrubin Hydrochloride Liposome injection
Reason Presence of Particulate matter: Particulate matter identified as glass.
Class I · High risk Ongoing
Lactated Ringer's Injection USP
Reason Presence of Particulate Matter.
Class I · High risk Ongoing
MG217 Multi-Symptom Treatment Cream & Skin Protectant
Reason Microbial Contamination of Non-Sterile Products: confirmed presence of Staphylococcus Aureus.
Class I · High risk Ongoing
Revitaderm Wound Care Gel
Reason Microbial contamination of Non-Sterile Product: samples identified the presence of Lysinibacillus fusiformis and other Bacillus spp
Class I · High risk Ongoing
Kian Pee Wan Capsules
Reason Marketed Without an Approved NDA/ANDA: Product contains undeclared drug ingredients dexamethasone and cyproheptadine.
Class I · High risk Ongoing
Magnesium Sulfate in Water for Injection
Reason Product mix up: a foil pouch labeled "Magnesium Sulfate in Water for Injection, 4 g/100 mL" actually contained an IV bag of Tranexamic Acid instead.
Class I · High risk Ongoing
Webcol Alcohol Prep pad
Reason Non-Sterility: microbial contamination identified as Paenibacillus phoenicis
Class I · High risk Ongoing
Udenyca
Reason Temperature Abuse. 116 cartons with specific serial numbers of Lot 2199821, were stored incorrectly in a controlled room temperature environment instead of the required refrigerated environment.
Class I · High risk Ongoing
Rheumacare capsules
Reason CGMP Deviations: product found to contain lead.
Class I · High risk Ongoing
MR. 7 SUPER 700000 capsules
Reason Marketed Without an Approved NDA/ANDA: FDA analysis revealed the presence of undeclared sildenafil and tadalafil
Class I · High risk Ongoing
ClearLife Allergy Nasal Spray
Reason Microbial Contamination of Non-Sterile Products: The products have been found to contain yeast/mold and microbial contamination identified as Achromobacter.
Class I · High risk Ongoing
ReBoost Nasal Spray
Reason Microbial Contamination of Non-Sterile Products: The products have been found to contain yeast/mold and microbial contamination identified as Achromobacter.
Class I · High risk Ongoing
Famotidine Injection
Reason Microbial Contamination of Sterile Products; out of limit results obtained for endotoxin testing.
Class I · High risk Ongoing
POTASSIUM CHLORIDE Inj.
Reason Labeling: Label Error on Declared Strength-The overwrap label may incorrectly identify the product as POTASSIUM CHLORIDE Inj. 10 mEq instead of POTASSIUM CHLORIDE Inj. 20 mEq
Class I · High risk Ongoing
POTASSIUM CHLORIDE Inj.
Reason Labeling: Label Error on Declared Strength-The overwrap label may incorrectly identify the product as POTASSIUM CHLORIDE Inj. 10 mEq instead of POTASSIUM CHLORIDE Inj. 20 mEq
Class I · High risk Ongoing
SILINTAN 25/pills
Reason Marketed Without an Approved NDA/ANDA: FDA analysis revealed the presence of undeclared meloxicam.