Class II · Moderate risk Terminated
Bumetanide Tablets
Reason Failed impurities/ degradation specifications: Product is Out of Specification for an unspecified degradation product.
FDA Drug Recalls
11,815 recalls · Class II, newest first
Class II · Moderate risk Terminated
Bumetanide Tablets
Reason Failed impurities/ degradation specifications: Product is Out of Specification for an unspecified degradation product.
Class II · Moderate risk Terminated
Elelyso
Reason Lack of assurance of sterility -Reports of loose metal ferrule crimps on vials for injection. The entire cap either lifted or dislodged while attempting to flip off the orange color plastic button.
Class II · Moderate risk Terminated
SparkleFresh Fluoride Toothpaste
Reason Microbial Contamination of Non-Sterile Product
Class II · Moderate risk Terminated
Lamotrigine Extended-Release Tablets
Reason Failed Dissolution Specifications: Out of Specification for Dissolution test (Buffer Stage) at the 5-hour time point during stability testing.
Class II · Moderate risk Terminated
Testosterone Cypionate/Proprinate 200 mg/10 mg/1 mL 30 mL Injectable
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Testosterone in Grapeseed Oil 200 mg/mL
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Zinc Sulfate 1 mg/mL MDV Injectable
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Water Sterile for Injection 250 mL IV Pharm D Solutions
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Vigamox Oph. Solution Pharm D Solutions
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Trimix T105 PGE/Phentolamine/Papaverine 10 mcg/30 mg/1 mg…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Trimix T-106 30PA-1PH-25A Aqueous Solution Pharm D Solutions
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Trimix T-101 Alprostadil/Phapaverine/Phentolamine 5.9 mcg/17.65…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Trimix ST9D 30PA-2PH-150A Aqueous Solution Pharm D Solutions
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Phentolamine 1 mg/Papaverine 15 mg/Alprostadil 150 mcg Aqueous…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Trimix ST-9B 30 PA-2PH-100A Aqueous Solution Pharm D Solutions
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Trimix ST-1 30PA-1.5PH-50A Aqueous Solution Pharm D Solutions
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Trimix Papaverine/Phentolamine/Alprostadil/Lidocaine 30 mg/1…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Trimix Papaverine/Phentolamine/Alprostadil 30 mg/1 mg/60 mcg…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Trimix Papaverine/Phentolamine/Alprostadil 30 mg/1 mg/20 mcg…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Trimix Papaverine/Phentolamine/Alprostadil 30 mg/1 mg/10 mcg…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Trimix AT-6 Papa 30 mg/Phent 4 mg/Atrop. 0.3 mg Injectable
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Trimix Alprostadil/ Phentolamine/Papavarin 40 mcg/1 mg/30 mg 10 mL Injectable
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Trimix 30-1-30 Papavarin 30 mg/Phentolamine 1 mg/Alprostadil 30…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Trimix T 101 Alprostadil/Papverine/Phentolamine 5.9 mcg/17.65…
Reason Lack of Assurance of Sterility