Class II · Moderate risk
Papaverine/Phentolamine
Lack of Assurance of Sterility; all sterile human compounded drugs 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/Hydroxocobalamin Preservative Free Unit Dose Syringes
Lack of Assurance of Sterility; all sterile human compounded drugs within expiry
Class II · Moderate risk
Methylcobalamin Preservative Free Prefilled
Lack of Assurance of Sterility; all sterile human compounded drugs within expiry
Class II · Moderate risk
Methylcobalamin Preservative Free Prefilled
Lack of Assurance of Sterility; all sterile human compounded drugs within expiry
Class II · Moderate risk
Methylcobalamin Mdv
Lack of Assurance of Sterility; all sterile human compounded drugs within expiry
Class II · Moderate risk
Methylcobalamin Mdv
Lack of Assurance of Sterility; all sterile human compounded drugs within expiry
Class II · Moderate risk
Methylcobalamin Mdv
Lack of Assurance of Sterility; all sterile human compounded drugs within expiry
Class II · Moderate risk
Methylcobalamin
Lack of Assurance of Sterility; all sterile human compounded drugs within expiry
Class II · Moderate risk
Methylcobalamin
Lack of Assurance of Sterility; all sterile human compounded drugs within expiry
Class II · Moderate risk
Methionine/Choline/Inositol
Lack of Assurance of Sterility; all sterile human compounded drugs within expiry
Class II · Moderate risk
Medroxyprogesterone Acetate
Lack of Assurance of Sterility; all sterile human compounded drugs within expiry
Class II · Moderate risk
Hydroxyprogesterone Caproate Oil
Lack of Assurance of Sterility; all sterile human compounded drugs within expiry
Class II · Moderate risk
Hydroxycobalamine/Methylcobalamine Pf Unit Dose
Lack of Assurance of Sterility; all sterile human compounded drugs within expiry
Class II · Moderate risk
Hydroxocobalamin Multidose Vial
Lack of Assurance of Sterility; all sterile human compounded drugs within expiry
Class II · Moderate risk
Hydroxocobalamin
Lack of Assurance of Sterility; all sterile human compounded drugs within expiry
Class II · Moderate risk
Hydroxocobalamin
Lack of Assurance of Sterility; all sterile human compounded drugs within expiry
Class II · Moderate risk
Hydroxocobalamin
Lack of Assurance of Sterility; all sterile human compounded drugs within expiry
Class II · Moderate risk
Glycopyrrolate
Lack of Assurance of Sterility; all sterile human compounded drugs within expiry
Class II · Moderate risk
Glutathione
Lack of Assurance of Sterility; all sterile human compounded drugs within expiry
Class II · Moderate risk
Glutathione Mdv
Lack of Assurance of Sterility; all sterile human compounded drugs within expiry
Class II · Moderate risk
Folic Acid
Lack of Assurance of Sterility; all sterile human compounded drugs within expiry
Class II · Moderate risk
Folic Acid
Lack of Assurance of Sterility; all sterile human compounded drugs within expiry
Class II · Moderate risk
Ethyl Alcohol
Lack of Assurance of Sterility; all sterile human compounded drugs within expiry
Class II · Moderate risk
Estradiol
Lack of Assurance of Sterility; all sterile human compounded drugs within expiry
Class II · Moderate risk
Estradiol
Lack of Assurance of Sterility; all sterile human compounded drugs within expiry
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