Class II · Moderate risk
MORphine 1 mg/mL
Lack of Assurance of Sterility: Potential leakage of bags.
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
Midazolam 1 mg/mL
Lack of Assurance of Sterility: Potential leakage of bags.
Class II · Moderate risk
MAGnesium 4gm in NS 100 mL
Lack of Assurance of Sterility: Potential leakage of bags.
Class II · Moderate risk
HYDROmorphone 1 mg/mL
Lack of Assurance of Sterility: Potential leakage of bags.
Class II · Moderate risk
Heparin 25
Lack of Assurance of Sterility: Potential leakage of bags.
Class II · Moderate risk
fentaNYL (10 mcg per mL)
Lack of Assurance of Sterility: Potential leakage of bags.
Class II · Moderate risk
EPINEPHrine
Lack of Assurance of Sterility: Potential leakage of bags.
Class II · Moderate risk
EPINEPHrine
Lack of Assurance of Sterility: Potential leakage of bags.
Class II · Moderate risk
ePHEDrine 50mg
Lack of Assurance of Sterility: Potential leakage of bags.
Class II · Moderate risk
ceFAZolin 2 gm in NS 100mL. ceFAZolin Sodium
Lack of Assurance of Sterility: Potential leakage of bags.
Class II · Moderate risk
0.2% ROPivacaine - OnQ Pump
Lack of Assurance of Sterility: Potential leakage of bags.
Class II · Moderate risk
Kit for the Preparation of Technetium Tc99m Medronate
Lack of assurance of sterility: Technetium TC-99M Medronate Kit has a reported breach of sterility.
Class II · Moderate risk
5% Dextrose Injection
Lack of assurance of sterility: Bags have potential to leak.
Class II · Moderate risk
0.9% Sodium Chloride Injection
Lack of assurance of sterility: Bags have potential to leak.
Class II · Moderate risk
0.9% Sodium Chloride Injection
Lack of assurance of sterility: Bags have potential to leak.
Class II · Moderate risk
0.9% Sodium Chloride Injection
Lack of assurance of sterility: Bags have potential to leak.
Class II · Moderate risk
0.45% Sodium Chloride Injection
Lack of assurance of sterility: Bags have potential to leak.
Class II · Moderate risk
Phenol 6% with Glycerin Inj 10 ml. Packaged in 10 ml vials…
Lack of sterility assurance.
Class II · Moderate risk
MIC "B" COMBO LIPOTROPIC 50 ml. Packaged in a 50ml MDV vial…
Lack of sterility assurance.
Class II · Moderate risk
Methylcobalamin 1000 mcg/mL 100 mL. RX Only. Packaged in 100ml…
Lack of sterility assurance.
Class II · Moderate risk
Glutathione 200 mg/mL 50 ml MDV. Rx Only. Packaged in 50 mL…
Lack of sterility assurance.
Class II · Moderate risk
Lidocaine 3% 10 ml. Rx Only. Packaged in 10 mL syringes…
Lack of sterility assurance.
Class II · Moderate risk
Glutathione 200 mg/mL 100 ml. Rx Only. Packaged in 50ml MDV…
Lack of sterility assurance.
Class II · Moderate risk
Cefazolin 2 Gm/20 mL 20 ml. Rx Only. Packaged in 20 mL syringes…
Lack of sterility assurance.
Class II · Moderate risk
Ropivacaine HCl 2 mg/mL 750 mL. Rx Only. Packaged in a ON-Q Pump…
Lack of sterility assurance.
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