Class II · Moderate risk
Human Chorionic Gonadotropin 10
Lack of Sterility Assurance.
Sterility & contamination
A product that must be sterile could not be assured sterile, or was contaminated. A top reason for injectables, eye drops and IV products - loss of sterility assurance can lead to serious infections.
6,317 FDA drug recalls with this cause, newest first.
This is the single biggest cause in the register by a wide margin. It covers products that had to be sterile - injectables, eye drops, certain ointments - but could not be verified sterile, or were found contaminated during testing. Most of these recalls come from compounding pharmacies and outsourcing facilities after an FDA inspection finds gaps in how sterile products were made. Sterility failures are treated seriously because the products involved have the least room for error, going straight into the bloodstream or the eye.
Class II · Moderate risk
B-complex
Lack of Sterility Assurance.
Class II · Moderate risk
Bacteriostatic Water for Injection
Lack of Sterility Assurance.
Class I · High risk
Amikacin Sulfate Injection
Non-Sterility:Microbial growth detected in sub lot of Amikacin Sulfate Injection, USP 1gm/4 mL (250mg/mL) and Prochlorperazine Edisylate Injection, USP 10mg/2mL (5mg/mL) .
Class I · High risk
Prochlorperazine Edisylate Injection
Non-Sterility:Microbial growth detected in sub lot of Amikacin Sulfate Injection, USP 1gm/4 mL (250mg/mL) and Prochlorperazine Edisylate Injection, USP 10mg/2mL (5mg/mL) .
Class II · Moderate risk
Bevacizumab 2.5 mg/0.1 mL
Lack of assurance of sterility
Class II · Moderate risk
Ketorolac Tromethamine Injection
Lack of Sterility Assurance: Microbial growth detected during a routine simulation of the manufacturing process, which represents the potential introduction of microorganisms into the products.
Class II · Moderate risk
Volumex (Iodinated I 131 Albumin)
Lack of Assurance of Sterility: environmental monitoring report exceeds limits, therefore sterility cannot be assured.
Class II · Moderate risk
DelNido Cardioplegia
Lack of sterility assurance.
Class II · Moderate risk
Vancomycin 2000 mg in 0.9% Sodium Chloride 500 mL bag
Lack of sterility assurance.
Class II · Moderate risk
Vancomycin 1750 mg in 0.9% Sodium Chloride 500 mL bag
Lack of sterility assurance.
Class II · Moderate risk
Vancomycin 1500 mg in NS 250 mL bag
Lack of sterility assurance.
Class II · Moderate risk
Vancomycin 1250 mg in NS 250 mL bag
Lack of sterility assurance.
Class II · Moderate risk
Vancomycin 1000 mg in NS 250 mL bag
Lack of sterility assurance.
Class II · Moderate risk
Sodium Citrate 4%
Lack of sterility assurance.
Class II · Moderate risk
Sodium Bicarbonate 150 mEq in D5W 1000 mL bags
Lack of sterility assurance.
Class II · Moderate risk
Phenylephrine 40 mg in 0.9% Sodium Chloride 250 mL bag
Lack of sterility assurance.
Class II · Moderate risk
Phenylephrine 20 mg NS 250 mL bag
Lack of sterility assurance.
Class II · Moderate risk
Phenylephrine 0.8 mg/10 mL NS
Lack of sterility assurance.
Class II · Moderate risk
Heparin Pork 30
Lack of sterility assurance.
Class II · Moderate risk
Chlorothiazide 100 mg
Lack of sterility assurance.
Class II · Moderate risk
CefTRIAXone 1 GM
Lack of sterility assurance.
Class II · Moderate risk
CeFAZolin 3 gm 100 mg/mL
Lack of sterility assurance.
Class II · Moderate risk
CeFAZolin 2 GM a) in NS 100 mL bag
Lack of sterility assurance.
Class II · Moderate risk
CeFAZolin 1 GM a) in NS 100 mL bag
Lack of sterility assurance.
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