Class II · Moderate risk
Gentamicin 80mg/60 mL Irrigation
Lack of Assurance of Sterility
FDA Drug Recalls
5,405 recalls, newest first
Class II · Moderate risk
*Mitomycin 0.04% Ophth DR eye drops
Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.
Class II · Moderate risk
C-*Gentamicin/Bacitracin Bladder Irrigation in N.S.
Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.
Class II · Moderate risk
*Morphine 2 mg/mL Cassette
Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.
Class II · Moderate risk
C-*Vancomycin Opthal 14 mg drops
Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.
Class II · Moderate risk
C-*Albumin Eye Drop 10% S
Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.
Class II · Moderate risk
Sodium Chloride 0.9% Injection
CGMP Deviation: Chemical indicators were not positioned properly during sterilization process.
Class II · Moderate risk
Elelyso (taliglucerase alfa)
Lack of Assurance of Sterility--Reports of loose metal ferrule crimps on vials for injection. The entire cap either lifted or dislodged while attempting to flip off the orange color plastic button.
Class II · Moderate risk
Zinc Chloride Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Cholecalciferol
Lack of Assurance of Sterility
Class II · Moderate risk
Cholecalciferol
Lack of Assurance of Sterility
Class II · Moderate risk
Triamcinolone Diacetate Injectable Suspension
Lack of Assurance of Sterility
Class II · Moderate risk
Triamcinolone Diacetate Injectable Suspension
Lack of Assurance of Sterility
Class II · Moderate risk
Triamcinolone Diacetate Injectable Suspension
Lack of Assurance of Sterility
Class II · Moderate risk
Triamcinolone Acetonide
Lack of Assurance of Sterility
Class II · Moderate risk
Triamcinolone Acetonide
Lack of Assurance of Sterility
Class II · Moderate risk
Triamcinolone Acetonide/Bupivacaine Hydrochloride Injectable Suspension
Lack of Assurance of Sterility
Class II · Moderate risk
Testosterone Cypionate/Progesterone Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Testosterone Cypionate Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Testosterone Cypionate Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Super MIC Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Selenium Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Pyridoxine Hydrochloride Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Iohexol
Lack of Assurance of Sterility
Class II · Moderate risk
Nicotinamide Adenine Dinucleotide
Lack of Assurance of Sterility