Class II · Moderate risk
Pe1/Papav/Phen 20mcg/30mg/2mg/Ml
Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
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
Pe1/Papav/Atrop/Chloprom** 7mcg/8.7mg/0.1mg/1.8mg/Ml
Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
Class II · Moderate risk
Papaverine/Phentolamine 30mg/0.5mg/Ml
Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
Class II · Moderate risk
Nadh 10mg/Ml
Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
Class II · Moderate risk
Mitomycin 0.4mg/Ml
Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
Class II · Moderate risk
Mitomycin 0.2mg/Ml
Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
Class II · Moderate risk
Methylcobalamin 12.5mg/Ml
Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
Class II · Moderate risk
Methotrexate Intravitreal
Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
Class II · Moderate risk
Methion/Inosit/Choline/Cyanocobal 25mg/50mg/50mg/1mg/Ml
Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
Class II · Moderate risk
Magnesium Chloride Hexahydrate-Pf- 200mg/Ml
Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
Class II · Moderate risk
Lidocaine-Pf- 5%
Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
Class II · Moderate risk
Levemir-Sts- 100u/Ml
Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
Class II · Moderate risk
Ketamine 50mg/Ml
Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
Class II · Moderate risk
Hydroxocobalamin-Pf- 1mg/Ml
Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
Class II · Moderate risk
Heparin/Lido Hcl/Sodium Bicarb 100u/2mg/16.8mg/Ml
Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
Class II · Moderate risk
Glycerin/Lidocaine Hcl/Epinephrine 31%
Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
Class II · Moderate risk
GLYCERIN STERILE 99% 2ML VIAL and 5ML VIAL
Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
Class II · Moderate risk
Glycerin 72%
Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
Class II · Moderate risk
Glutathione L Reduced 100mg/Ml
Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
Class II · Moderate risk
Gentamicin Bladder 0.08mg/Ml
Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
Class II · Moderate risk
Flurbiprofen -Corn Oil- 0.04%
Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
Class II · Moderate risk
Ethyl Alcohol 95%
Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
Class II · Moderate risk
Estradiol Cyp/Test Cyp- Ss Oil- 2mg/50mg/Ml
Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
Class II · Moderate risk
Estradiol 0.05% OPH Solution
Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
Class II · Moderate risk
Edetate Disodium
Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
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