Class II · Moderate risk
0.9% Sodium Chloride Injection
Lack of Assurance of Sterility; bags have the potential to leak
FDA Drug Recalls
343 recalls, newest first
Class II · Moderate risk
5% Dextrose Injection
Lack of Assurance of Sterility; bags have the potential to leak
Class II · Moderate risk
Meropenem for Injection
Lack of assurance of sterility: loss of container integrity.
Class II · Moderate risk
Elelyso (taliglucerase alfa)
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
Testosterone Cypionate/Proprinate 200 mg/10 mg/1 mL 30 mL Injectable
Lack of Assurance of Sterility
Class II · Moderate risk
Testosterone in Grapeseed Oil 200 mg/mL
Lack of Assurance of Sterility
Class II · Moderate risk
Zinc Sulfate 1 mg/mL MDV Injectable
Lack of Assurance of Sterility
Class II · Moderate risk
Water Sterile for Injection 250 mL IV Pharm D Solutions
Lack of Assurance of Sterility
Class II · Moderate risk
Vigamox Oph. Solution Pharm D Solutions
Lack of Assurance of Sterility
Class II · Moderate risk
Trimix T105 PGE/Phentolamine/Papaverine 10 mcg/30 mg/1 mg Injectable Pharm D Solutions
Lack of Assurance of Sterility
Class II · Moderate risk
Trimix T-106 30PA-1PH-25A Aqueous Solution Pharm D Solutions
Lack of Assurance of Sterility
Class II · Moderate risk
Trimix T-101 Alprostadil/Phapaverine/Phentolamine 5.9 mcg/17.65…
Lack of Assurance of Sterility
Class II · Moderate risk
Trimix ST9D 30PA-2PH-150A Aqueous Solution Pharm D Solutions
Lack of Assurance of Sterility
Class II · Moderate risk
Phentolamine 1 mg/Papaverine 15 mg/Alprostadil 150 mcg Aqueous Solution Pharm D Solutions
Lack of Assurance of Sterility
Class II · Moderate risk
Trimix ST-9B 30 PA-2PH-100A Aqueous Solution Pharm D Solutions
Lack of Assurance of Sterility
Class II · Moderate risk
Trimix ST-1 30PA-1.5PH-50A Aqueous Solution Pharm D Solutions
Lack of Assurance of Sterility
Class II · Moderate risk
Trimix Papaverine/Phentolamine/Alprostadil/Lidocaine 30 mg/1…
Lack of Assurance of Sterility
Class II · Moderate risk
Trimix Papaverine/Phentolamine/Alprostadil 30 mg/1 mg/60 mcg Powder Pharm D Solutions
Lack of Assurance of Sterility
Class II · Moderate risk
Trimix Papaverine/Phentolamine/Alprostadil 30 mg/1 mg/20 mcg Powder Pharm D Solutions
Lack of Assurance of Sterility
Class II · Moderate risk
Trimix Papaverine/Phentolamine/Alprostadil 30 mg/1 mg/10 mcg Powder Pharm D Solutions
Lack of Assurance of Sterility
Class II · Moderate risk
Trimix AT-6 Papa 30 mg/Phent 4 mg/Atrop. 0.3 mg Injectable
Lack of Assurance of Sterility
Class II · Moderate risk
Trimix Alprostadil/ Phentolamine/Papavarin 40 mcg/1 mg/30 mg 10 mL Injectable
Lack of Assurance of Sterility
Class II · Moderate risk
Trimix 30-1-30 Papavarin 30 mg/Phentolamine 1 mg/Alprostadil 30 mg/mL Aqueous Solution
Lack of Assurance of Sterility
Class II · Moderate risk
Trimix T 101 Alprostadil/Papverine/Phentolamine 5.9 mcg/17.65…
Lack of Assurance of Sterility
Class II · Moderate risk
Trimix QM10 Papaverine 30 mg/Phentolamine 4 mg/Atropine 1 mg/PGE 150 mcg/mL Injectable
Lack of Assurance of Sterility