Class I · High risk
Hydromorphone
Non-Sterility: Confirmed customer complaints of glass product container vials that may be empty or cracked.
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 I · High risk
Hydromorphone
Non-Sterility: Confirmed customer complaints of glass product container vials that may be empty or cracked.
Class II · Moderate risk
100 mcg / mL Phenylephrine HCl
Lack of assurance of sterility: Three lots were released where there was a failure to follow proper testing and investigation procedures. Product may be out of specification (OOS) for endotoxin.
Class II · Moderate risk
0.2% Ropivacaine HCI
Lack of assurance of sterility: Three lots were released where there was a failure to follow proper testing and investigation procedures. Product may be out of specification (OOS) for endotoxin.
Class II · Moderate risk
15 units Oxytocin added to 0.9% Sodium Chloride Injection
Lack of assurance of sterility: Three lots were released where there was a failure to follow proper testing and investigation procedures. Product may be out of specification (OOS) for endotoxin.
Class II · Moderate risk
DOXOrubicin Hydrochloride Liposome Injection
Lack Of Assurance Of Sterility
Class I · High risk
Hcg 5
Non-Sterility
Class II · Moderate risk
Nicardipine HCl in 0.9% Sodium Chloride in all strengths
Lack of sterility assurance.
Class II · Moderate risk
Dexamethasone Sodium Phosphate added to 5% Dextrose in all strengths
Lack of sterility assurance.
Class II · Moderate risk
Rocuronium Bromide in all strengths
Lack of sterility assurance.
Class II · Moderate risk
Methadone HCl Injection in all strengths
Lack of sterility assurance.
Class II · Moderate risk
Meperidine HCl in 0.9% Sodium Chloride in all strengths
Lack of sterility assurance.
Class II · Moderate risk
Esmolol HCl in all strengths
Lack of sterility assurance.
Class II · Moderate risk
Dexamethasone Sodium Phosphate added to 0.9% Sodium Chloride in all strengths
Lack of sterility assurance.
Class II · Moderate risk
Vecuronium Bromide in Sterile Water for Injection in all strengths
Lack of sterility assurance.
Class II · Moderate risk
Neostigmine Methylsulfate Injection in all strengths
Lack of sterility assurance.
Class II · Moderate risk
Labetalol HCl in 0.9% Sodium Chloride in all strengths
Lack of sterility assurance.
Class II · Moderate risk
Nicardipine HCl in all strengths
Lack of sterility assurance.
Class II · Moderate risk
Ropivacaine HCl Injection in all strengths
Lack of sterility assurance.
Class II · Moderate risk
HYDROmorphone HCl in 5% Dextrose in all strengths
Lack of sterility assurance.
Class II · Moderate risk
Atropine Sulfate Injection in all strengths
Lack of sterility assurance.
Class II · Moderate risk
Lidocaine HCl in 0.9% Sodium Chloride in all strengths
Lack of sterility assurance.
Class II · Moderate risk
Glycopyrrolate in all strengths
Lack of sterility assurance.
Class II · Moderate risk
Ropivacaine HCl in 0.9% Sodium Chloride in all strengths
Lack of sterility assurance.
Class II · Moderate risk
Ketamine HCl Injection in all strengths
Lack of sterility assurance.
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