Class II · Moderate risk
Cefoxitin
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
Cefepime
Lack of sterility assurance
Class II · Moderate risk
CEFAZOLIN 5mg/mL/HEPARIN 100unit/ml 1.5ML SYR
Lack of sterility assurance
Class II · Moderate risk
Cefazolin
Lack of sterility assurance
Class II · Moderate risk
Caspofungin 50mg in Ns 100ml
Lack of sterility assurance
Class II · Moderate risk
Ampicillin/Sulbactam 3GM IN NS 100ML
Lack of sterility assurance
Class II · Moderate risk
Ampicillin 8gm in Ns 400ml
Lack of sterility assurance
Class II · Moderate risk
Ampicillin 12gm in Ns 600m
Lack of sterility assurance
Class II · Moderate risk
Amikacin 450MG IN NS 45ML
Lack of sterility assurance
Class II · Moderate risk
0.9% Sodium Chloride
Lack of sterility assurance
Class II · Moderate risk
Voriconazole 10mg/Ml
Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
Class II · Moderate risk
Vitamin D3-Aqueous- 10
Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
Class II · Moderate risk
Vancomycin Fortified 10mg/Ml
Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
Class II · Moderate risk
Tobramycin Fortified 15mg/Ml Oph Solution
Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
Class II · Moderate risk
Thiamine/Ribofla/Niacinami/Dexpanth/Pyridox/Hydroxycobal 25mg/25mg/25mg/25mg/25mg/20mg/Ml
Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
Class II · Moderate risk
Testosterone 3%
Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
Class II · Moderate risk
Tacrolimus 0.03% Oph Solution Tacrolimus 0.1%
Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
Class II · Moderate risk
Semaglutide 0.5mg/Ml
Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
Class II · Moderate risk
Scopolamine Hydrobromide 0.25% Oph Solution
Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
Class II · Moderate risk
Prostaglandin
Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
Class II · Moderate risk
Progesterone-Gs Oil- 100mg/Ml
Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
Class II · Moderate risk
Polyhexamethylene Biguanide 0.2mg/Ml
Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
Class II · Moderate risk
Polidocanol 50mg/Ml
Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
Class II · Moderate risk
Phosphatidylcholine/Deoxycholic Acid
Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
Class II · Moderate risk
Phenol 10%
Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
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