Class II · Moderate risk
Lactated Ringers
Lack of Assurance of Sterility: Product sterility cannot be guaranteed.
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
Nafcillin 2GM in NS
Lack of Assurance of Sterility: Product sterility cannot be guaranteed.
Class II · Moderate risk
Ampicillin/Sulbactam 12GM in NS
Lack of Assurance of Sterility: Product sterility cannot be guaranteed.
Class II · Moderate risk
FLUCONAZOLE IN NACL 400MG in NS
Lack of Assurance of Sterility: Product sterility cannot be guaranteed.
Class II · Moderate risk
PENICILLIN in D5W
Lack of Assurance of Sterility: Product sterility cannot be guaranteed.
Class II · Moderate risk
MORPHINE 10MG/ML in NS
Lack of Assurance of Sterility: Product sterility cannot be guaranteed.
Class II · Moderate risk
ZOSYN (pipericillin/tazobactam)
Lack of Assurance of Sterility: Product sterility cannot be guaranteed.
Class II · Moderate risk
Cefepime
Lack of Assurance of Sterility: Product sterility cannot be guaranteed.
Class II · Moderate risk
Invanz (ertapenem)
Lack of Assurance of Sterility: Product sterility cannot be guaranteed.
Class II · Moderate risk
ASCORBIC ACID 500MG/Syringe
Lack of Assurance of Sterility: Product sterility cannot be guaranteed.
Class II · Moderate risk
GANCICLOVIR in NS
Lack of Assurance of Sterility: Product sterility cannot be guaranteed.
Class II · Moderate risk
Hydromorphone HCL
Lack of Assurance of Sterility: Product sterility cannot be guaranteed.
Class II · Moderate risk
Ondansetron HCL 8mg
Lack of Assurance of Sterility: Product sterility cannot be guaranteed.
Class II · Moderate risk
Vancomycin HCL
Lack of Assurance of Sterility: Product sterility cannot be guaranteed.
Class II · Moderate risk
DOBUTAMINE HCL in D5W
Lack of Assurance of Sterility: Product sterility cannot be guaranteed.
Class II · Moderate risk
CEFTRIAXONE in NS
Lack of Assurance of Sterility: Product sterility cannot be guaranteed.
Class II · Moderate risk
Dextrose-NaCl
Lack of Assurance of Sterility: Product sterility cannot be guaranteed.
Class II · Moderate risk
POTASSIUM CHLORIDE in D 5 1/2NS
Lack of Assurance of Sterility: Product sterility cannot be guaranteed.
Class II · Moderate risk
Intralipid
Lack of Assurance of Sterility: Product sterility cannot be guaranteed.
Class II · Moderate risk
Solumedrol
Lack of Assurance of Sterility: Product sterility cannot be guaranteed.
Class II · Moderate risk
Milrinone in 0.45% NS
Lack of Assurance of Sterility: Product sterility cannot be guaranteed.
Class II · Moderate risk
Cefazolin
Lack of Assurance of Sterility: Product sterility cannot be guaranteed.
Class II · Moderate risk
Parenteral Amino Acid Infusion 10%
Lack of Assurance of Sterility: Product sterility cannot be guaranteed.
Class II · Moderate risk
Sod Chloride
Lack of Assurance of Sterility: Product sterility cannot be guaranteed.
Class II · Moderate risk
CUBICIN (daptomycin)
Lack of Assurance of Sterility: Product sterility cannot be guaranteed.
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