Class II · Moderate risk Terminated
Combigan
Reason cGMP Deviations
FDA Drug Recalls
17,898 recalls, newest first
Class III · Low risk Terminated
Diclofenac Sodium Topical Solution
Reason Defective Container: firm discovered samples stored horizontally as well as product quality complaints from customers for bottles leaking.
Class III · Low risk Terminated
Repairwear Laser Focus Line Smoothing Cream Broad Spectrum SPF 15
Reason Defective container: Ineffective seal between the cap and jar of the affected product.
Class I · High risk Terminated
8.4% Sodium Bicarbonate Injection
Reason Presence of Particulate Matter; glass particulates
Class III · Low risk Terminated
Clindamycin Injection
Reason Failed Impurities/Degradation Specifications: High out-of-specification (OOS) results were demonstrated for several specified impurities at the 24-month time point
Class III · Low risk Terminated
Clindamycin Injection
Reason Failed Impurities/Degradation Specifications: High out-of-specification (OOS) results were demonstrated for several specified impurities at the 24-month time point
Class III · Low risk Terminated
Clindamycin Injection
Reason Failed Impurities/Degradation Specifications: High out-of-specification (OOS) results were demonstrated for several specified impurities at the 24-month time point
Class III · Low risk Terminated
Cleocin Phosphate
Reason Failed Impurities/Degradation Specifications: High out-of-specification (OOS) results were demonstrated for several specified impurities at the 24-month time point
Class III · Low risk Terminated
Cleocin Phosphate
Reason Failed Impurities/Degradation Specifications: High out-of-specification (OOS) results were demonstrated for several specified impurities at the 24-month time point
Class III · Low risk Terminated
Cleocin Phosphate
Reason Failed Impurities/Degradation Specifications: High out-of-specification (OOS) results were demonstrated for several specified impurities at the 24-month time point
Class I · High risk Terminated
Blue Fusion Capsules
Reason Marketed Without An Approved NDA/ANDA: FDA analysis found this product to contain undeclared ingredients: Sildenafil, Tadalafil, desmethyl carbodenafil, dithiodesmethyl carbodenafil, scutellarin, and daidzein.
Class II · Moderate risk Terminated
Losartan 50mg Tablet
Reason CGMP Deviations; Detection of trace amounts of an unexpected impurity found in an active pharmaceutical ingredient (API) - N-Methylnitrosobutyric acid (NMBA).
Class II · Moderate risk Terminated
Phenylephrine HCl
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Morphine Sulfate 30 mg/30 mL
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Phenylephrine HCl
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Heparin 5
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Heparin 10 Units/10 mL 10 Units in 0.45% Sodium Chloride
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Esmolol HCl Injectable Solution 100 mg/10 mL
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Phenylephrine HCl
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
2% Lidocaine HCl Injectable Solution
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
2% Lidocaine HCl Injectable Solution
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Glycopyrrolate 0.6 mg/3 mL
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Neostigmine Methylsulfate Injection Solution 5 mg/5mL
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Phenylephrine HCl
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Phenylephrine HCl
Reason Lack of Assurance of Sterility