Class II · Moderate risk Ongoing
TRP Natural Eyes
Reason Lack of Assurance of Sterility
FDA Drug Recalls
17,898 recalls, newest first
Class III · Low risk Terminated
HydrALAZINE Hydrochloride Tablets
Reason Failed Impurities/Degradation Specifications: Out of Specification results in the repackaged product for impurities at the 12-month time point.
Class II · Moderate risk Terminated
Sucralfate Oral Suspension 1g per 10mL
Reason Superpotent/Subpotent single ingredient Drug: Out of Specification Assay results
Class III · Low risk Terminated
Clearasil Rapid Rescue Deep Treatment Pads
Reason Labeling: Label Error on Declared Strength: The incorrect label on the back of the product packaging.
Class I · High risk Ongoing
Dr. Berne's MSM DROPS 5% Solution
Reason Non-Sterility
Class II · Moderate risk Ongoing
Dr. Berne's MSM DROPS 5% Solution
Reason CGMP Deviations
Class II · Moderate risk Ongoing
Dr. Berne's Organic Castor Oil Eye Drops
Reason CGMP Deviations
Class II · Moderate risk Ongoing
Dr. Berne's MSM MIST 15% Solution
Reason CGMP Deviations
Class II · Moderate risk Ongoing
Dr. Berne's MSM DROPS 15% Solution
Reason CGMP Deviations
Class I · High risk Terminated
WEFUN Capsules 825 mg
Reason Marketed Without an Approved NDA/ANDA: FDA analysis found the product to be tainted with sildenafil, an ingredient found in a FDA approved product for the treatment of male sexual enhancement, making this an unapproved drug.
Class II · Moderate risk Terminated
Digoxin Tablets
Reason Labeling: Label Mix-Up- Bottles labeled as Digoxin Tablets, USP 0.125 mg contain Digoxin Tablets, USP 0.25mg and bottles labeled as Digoxin Tablets, USP 0.25mg contain Digoxin Tablets, USP 0.125mg.
Class I · High risk Terminated
Digoxin Tablets
Reason Labeling: Label Mix-Up- Bottles labeled as Digoxin Tablets, USP 0.125 mg contain Digoxin Tablets, USP 0.25mg and bottles labeled as Digoxin Tablets, USP 0.25mg contain Digoxin Tablets, USP 0.125mg.
Class II · Moderate risk Completed
BD ChloraPrep Clear
Reason Stability data does not support expiry: Shelf-life of the impacted lots of BD ChloraPrep" Clear 1 mL Applicator cannot be substantiated beyond 12-months although labeled with 36-month expiry. Stability studies indicate that the impacted lots, if stored at 30¿C/75% relative humidity continuously beyond 12 months, may exhibit growth of Aspergillus penicillioides.
Class II · Moderate risk Terminated
Doxil
Reason CGMP Deviations: Product was exposed to temperatures exceeding the labeled storage conditions during transportation were released by mistake.
Class III · Low risk Terminated
Clindamycin Phosphate Topical Solution USP
Reason Defective Container: slow leakage under the cap
Class II · Moderate risk Terminated
Florbetaben F-18
Reason Lack of Assurance of Sterility: out-of-specification test results observed for Filter Integrity Test (FIT).
Class II · Moderate risk Ongoing
Humanrace Suncare
Reason Subpotent Drug: Product does not contain SPF that is declared on the label.
Class II · Moderate risk Ongoing
Humanrace Suncare
Reason Subpotent Drug: Product does not contain SPF that is declared on the label.
Class III · Low risk Completed
Sabril
Reason Cross contamination with other products
Class II · Moderate risk Terminated
dilTIAZem 125mg/125mL
Reason Lack of Assurance of Sterility:Lack of validation data for sanitization cycles
Class II · Moderate risk Terminated
dilTIAZem 125mg/125mL
Reason Lack of Assurance of Sterility:Lack of validation data for sanitization cycles
Class II · Moderate risk Terminated
vancomycin added to 0.9% Sodium Chloride
Reason Lack of Assurance of Sterility:Lack of validation data for sanitization cycles
Class II · Moderate risk Terminated
heparin added to 0.9% sodium chloride
Reason Lack of Assurance of Sterility:Lack of validation data for sanitization cycles
Class II · Moderate risk Terminated
oxyTOCIN
Reason Lack of Assurance of Sterility:Lack of validation data for sanitization cycles
Class II · Moderate risk Terminated
oxyTOCIN 30 units added to 0.9% sodium chloride 500 mL
Reason Lack of Assurance of Sterility:Lack of validation data for sanitization cycles