Class II · Moderate risk
2% Lidocaine HCl Injectable Solution
Lack of Assurance of Sterility
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
2% Lidocaine HCl Injectable Solution
Lack of Assurance of Sterility
Class II · Moderate risk
Glycopyrrolate 0.6 mg/3 mL
Lack of Assurance of Sterility
Class II · Moderate risk
Neostigmine Methylsulfate Injection Solution 5 mg/5mL
Lack of Assurance of Sterility
Class II · Moderate risk
Phenylephrine HCl
Lack of Assurance of Sterility
Class II · Moderate risk
Phenylephrine HCl
Lack of Assurance of Sterility
Class II · Moderate risk
Glycopyrrolate Injectable Solution 1 mg/5 mL
Lack of Assurance of Sterility
Class II · Moderate risk
Phenylephrine HCl
Lack of Assurance of Sterility
Class II · Moderate risk
Midazolam Benzodiazepine 50 mg/50 mL
Lack of Assurance of Sterility
Class II · Moderate risk
fentaNYL 2500 mcg/250 mL Injectable Solution
Lack of Assurance of Sterility
Class II · Moderate risk
fentaNYL 1000 mcg/100 mL Injectable Solution Fentanyl 0.9% Sodium Chloride
Lack of Assurance of Sterility
Class II · Moderate risk
HYDROmorphone HCl 1 mg in 0.9% Sodium Chloride
Lack of Assurance of Sterility
Class II · Moderate risk
Dr. Berne's MSM DROPS 15% Solution
Lack of Assurance of Sterility: Product is not terminally sterialized and not tested per USP 71.
Class II · Moderate risk
Red Eye
Lack of Assurance of Sterility: Product is not terminally sterialized and not tested per USP 71.
Class II · Moderate risk
Dry Eye
Lack of Assurance of Sterility: Product is not terminally sterialized and not tested per USP 71.
Class II · Moderate risk
15% Msm
Lack of Assurance of Sterility: Product is not terminally sterialized and not tested per USP 71.
Class II · Moderate risk
Volumex (Iodinated I 131 Albumin)
Lack of Assurance of Sterility: preliminary environmental monitoring report exceeds limits, therefore sterility cannot be assured.
Class II · Moderate risk
Papaverine-Phentolamine-Pge1 17.44-0.64mg-5.8mcg/Ml* Injectable
Lack of Processing Controls: Insanitary conditions observed during compounding of sterile drugs during recent FDA Inspection.
Class II · Moderate risk
Papaverine-Phentolamine-Pge1 17.44-0.58mg-5.8mcg/Ml* Injectable
Lack of Processing Controls: Insanitary conditions observed during compounding of sterile drugs during recent FDA Inspection.
Class II · Moderate risk
Papaverine-Phentolamine-Pge1 15-0.25mg-6mcg/Ml Injectable
Lack of Processing Controls: Insanitary conditions observed during compounding of sterile drugs during recent FDA Inspection.
Class II · Moderate risk
Papaverine-Phentolamine-Pge1 30-1 Mg-20 Mcg/Ml* Injectable
Lack of Processing Controls: Insanitary conditions observed during compounding of sterile drugs during recent FDA Inspection.
Class II · Moderate risk
Papaverine-Phentolamine-Pge1 9-1 Mg-10 Mcg/Ml* Injectable
Lack of Processing Controls: Insanitary conditions observed during compounding of sterile drugs during recent FDA Inspection.
Class II · Moderate risk
Papaverine-Phentolamine-Pge1 22.5-0.8mg-8.3mcg/Ml Injectable
Lack of Processing Controls: Insanitary conditions observed during compounding of sterile drugs during recent FDA Inspection.
Class II · Moderate risk
Papaverine-Phentolamine-Pge1 17.64-0.58mg-5.88mcg/Ml* Injectable
Lack of Processing Controls: Insanitary conditions observed during compounding of sterile drugs during recent FDA Inspection.
Class II · Moderate risk
Papaverine-Phentolamine-Pge1 16.6-0.55 Mg-11.1 Mcg/Ml* Injectable
Lack of Processing Controls: Insanitary conditions observed during compounding of sterile drugs during recent FDA Inspection.
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