Class II · Moderate risk
Tri-Mix 10mcg+0.5mg+15mg/Ml
Lack of Assurance of Sterility: all sterile compounded products within expiry
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
Methylcobalamin 1000mcg/Ml
Lack of Assurance of Sterility: all sterile compounded products within expiry
Class II · Moderate risk
Prostaglandin Pge-1 40mcg/Ml
Lack of Assurance of Sterility: all sterile compounded products within expiry
Class II · Moderate risk
Sermorelin 6mg/6mL Lyophilized Powder
Lack of Assurance of Sterility: A recent FDA inspection found that this product was not being compounded in an area appropriate for lyophilization which may lead to a lack of sterility assurance.
Class II · Moderate risk
P-P (Cobal)
Lack of assurance of sterility
Class II · Moderate risk
P-P (Cobal)
Lack of assurance of sterility
Class II · Moderate risk
P-P-P (Cobal)
Lack of assurance of sterility
Class II · Moderate risk
P-P-P (Cobal)
Lack of assurance of sterility
Class II · Moderate risk
P-P-P (Cobal)
Lack of assurance of sterility
Class II · Moderate risk
Testosterone Cypionate
Lack of assurance of sterility
Class II · Moderate risk
Testosterone Cypionate
Lack of assurance of sterility
Class II · Moderate risk
Acetylcysteine 10% Opthalmic Solution
Lack of assurance of sterility
Class II · Moderate risk
Hydroxocobalamin 20 mg/mL Injection
Lack of assurance of sterility
Class II · Moderate risk
Methylcobalamin
Lack of assurance of sterility
Class II · Moderate risk
P-P (Cobal)
Lack of assurance of sterility
Class II · Moderate risk
P-P-P (Cobal)
Lack of assurance of sterility
Class II · Moderate risk
Methylcobalamin
Lack of assurance of sterility
Class II · Moderate risk
MYCAMINE (micafungin sodium)
Lack of Assurance of Sterility: Product sterility cannot be guaranteed.
Class II · Moderate risk
Dextrose-5% Lactated Ringers
Lack of Assurance of Sterility: Product sterility cannot be guaranteed.
Class II · Moderate risk
Tobramycin 120MG
Lack of Assurance of Sterility: Product sterility cannot be guaranteed.
Class II · Moderate risk
Gentamicin
Lack of Assurance of Sterility: Product sterility cannot be guaranteed.
Class II · Moderate risk
Solu-Cortef
Lack of Assurance of Sterility: Product sterility cannot be guaranteed.
Class II · Moderate risk
CLINDAMYCIN 120MG in NS
Lack of Assurance of Sterility: Product sterility cannot be guaranteed.
Class II · Moderate risk
AZACTAM (aztreonam)
Lack of Assurance of Sterility: Product sterility cannot be guaranteed.
Class II · Moderate risk
Cancidas (caspofungin acetate)
Lack of Assurance of Sterility: Product sterility cannot be guaranteed.
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