Class II · Moderate risk Ongoing
Nystatin 150 Mu
Reason Labeling: Label Error on Declared Strength: Assay value on the label is incorrect.
FDA Drug Recalls
17,898 recalls, newest first
Class II · Moderate risk Ongoing
Nystatin 2 Bu
Reason Labeling: Label Error on Declared Strength: Assay value on the label is incorrect.
Class II · Moderate risk Ongoing
Nystatin 500 Mu
Reason Labeling: Label Error on Declared Strength: Assay value on the label is incorrect.
Class II · Moderate risk Ongoing
Nystatin 5bu
Reason Labeling: Label Error on Declared Strength: Assay value on the label is incorrect.
Class III · Low risk Terminated
Eprontia
Reason Failed Impurities/Degradation Specifications: Out of specification Impurity C (4,5-desisopropylidene topiramate) result observed during routine stability testing at 18 months.
Class II · Moderate risk Terminated
Liothyronine Sodium Tablets
Reason Failed Impurities/Degradation Specifications
Class I · High risk Ongoing
Magnum XXL 9800
Reason Marketed without an approved NDA/ANDA: Magnum XXL found to contain undeclared active pharmaceutical ingredient (API) - Sildenafil.
Class II · Moderate risk Completed
ROPivacaine HCl 0.2% PF in Sodium Chloride 1
Reason STAQ Pharma Inc. received consumer complaints related to leaking bags and other potential bag concerns. Upon investigation, they determine the source of the issue was with the bag manufacturer who released bags Lot # 134142-001A which had failed internal QC tests for leaks.
Class II · Moderate risk Terminated
Thiamine HCl/Pyridoxine HCl 20 mg/mL /100mg/ml Injection Solution
Reason Presence of Particulate Matter.
Class II · Moderate risk Terminated
B-Complex
Reason Presence of Particulate Matter.
Class I · High risk Completed
TING 2% Miconazole Nitrate Athlete's Foot Spray Antifungal Spray Powder
Reason Chemical Contamination; presence of benzene.
Class II · Moderate risk Terminated
Penicillamine Tablets USP 250 mg
Reason Failed Dissolution Specifications
Class I · High risk Ongoing
SANDIMMUNE Oral Solution
Reason Crystallization: bottles of Sandimmune Oral Solution were determined to contain crystals
Class II · Moderate risk Completed
ceFAZolin sodium in Sterile Water for injection
Reason Lack of assurance of sterility.
Class III · Low risk Terminated
buPROPion Hydrochloride Extended-Release Tablets
Reason Failed Dissolution Specifications
Class III · Low risk Completed
Votrient
Reason Failed Dissolution Specifications
Class I · High risk Completed
Vigabatrin for Oral Solution
Reason Defective Container: powder may leak out of the pouch
Class II · Moderate risk Completed
Ondansetron Injection
Reason Failed pH Specifications
Class I · High risk Ongoing
Up&Up brand dry eye relief
Reason Non-Sterility
Class I · High risk Ongoing
Rugby brand Lubricating Tears Eye Drops
Reason Non-Sterility
Class I · High risk Ongoing
Lubricant Eye Drops
Reason Non-Sterility
Class I · High risk Ongoing
Multi-action Relief Drops
Reason Non-Sterility
Class I · High risk Ongoing
Lubricant Gel Drops
Reason Non-Sterility
Class I · High risk Ongoing
Lubricant Gel Drops
Reason Non-Sterility
Class I · High risk Ongoing
CVS Health brand Mild Moderate Lubricating Eye Drops
Reason Non-Sterility