Class II · Moderate risk
Alprostadil 40 mcg/mL Injectable
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
Testosterone Cypionate in Sesame Oil Injectable
Lack of Assurance of Sterility
Class II · Moderate risk
Alprostadil 20 mcg/mL Injectable
Lack of Assurance of Sterility
Class II · Moderate risk
Chorionic Gonadotropin
Lack of Assurance of Sterility
Class II · Moderate risk
Ultra-Test
Lack of Assurance of Sterility
Class II · Moderate risk
ULTRA-TEST in Grapeseed Oil
Lack of Assurance of Sterility
Class II · Moderate risk
Nicotinamide Adenine Dinucleotide
Lack of Assurance of Sterility
Class II · Moderate risk
MIC Combo - Standard 15 mg/50 mg/100 mg/mL Injectable
Lack of Assurance of Sterility
Class II · Moderate risk
Phenylephrine HCl Injectable
Lack of Assurance of Sterility
Class II · Moderate risk
QUAD3 (Pap/Phen/Alpro/Atro)
Lack of Assurance of Sterility
Class II · Moderate risk
Testosterone Enanthate in Grapeseed Oil Injectable
Lack of Assurance of Sterility
Class II · Moderate risk
Ultra-Test
Lack of Assurance of Sterility
Class II · Moderate risk
Testosterone Cypionate in Grapeseed Oil Injectable
Lack of Assurance of Sterility
Class II · Moderate risk
Vancomycin 10 mg/mL in 0.9% Sodium Chloride
Lack of Assurance of Sterility; all compounded products within expiry produced using recalled filters
Class II · Moderate risk
Placebo for Prednisolone Acetate 1%
Lack of Assurance of Sterility; all compounded products within expiry produced using recalled filters
Class II · Moderate risk
Moxifloxacin 1 mg/mL in Sterile Balanced Salt Solution
Lack of Assurance of Sterility; all compounded products within expiry produced using recalled filters
Class II · Moderate risk
Mitomycin 0.02%
Lack of Assurance of Sterility; all compounded products within expiry produced using recalled filters
Class II · Moderate risk
Lidocaine HCl 1% - Phenylephrine HCl 1.5% in Sterile Water for Injection
Lack of Assurance of Sterility; all compounded products within expiry produced using recalled filters
Class II · Moderate risk
Cyclopentolate HCl 1% - Tropicamide 1% - PHENYLephrine HCl 2.5%…
Lack of Assurance of Sterility; all compounded products within expiry produced using recalled filters
Class II · Moderate risk
Cefuroxime Sodium 10 mg/mL in 0.9% Sodium Chloride
Lack of Assurance of Sterility; all compounded products within expiry produced using recalled filters
Class II · Moderate risk
Brilliant Blue G 0.025% in 0.9% Sodium Chloride
Lack of Assurance of Sterility; all compounded products within expiry produced using recalled filters
Class II · Moderate risk
Atropine Sulfate 0.01% in 0.9% Sodium Chloride
Lack of Assurance of Sterility; all compounded products within expiry produced using recalled filters
Class II · Moderate risk
Marcaine 0.5%
Lack of Assurance of Sterility and Subpotent Drug: defect in glass vial prevented stopper from forming a seal allowing water to ingress and dilute the product causing it to be less than the labeled potency.
Class II · Moderate risk
Marcaine 0.25%
Lack of Assurance of Sterility and Subpotent Drug: defect in glass vial prevented stopper from forming a seal allowing water to ingress and dilute the product causing it to be less than the labeled potency.
Class II · Moderate risk
Tri-Mix 18/1/10
Lack of Assurance of Sterility; medication was sterilized with a recalled filter
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