Class II · Moderate risk
Difluprednate Ophthalmic Emulsion 0.05%
Lack of Assurance of Sterility: Complaints received of defective container closure.
FDA Drug Recalls
398 recalls, newest first
Class II · Moderate risk
Bupivacaine HCl 0.375% w/v and Lidocaine HCl 2% w/v Solution for…
Lack of Assurance of Sterility
Class II · Moderate risk
fentaNYL Citrate in 0.9% Sodium Chloride
Lack of Assurance of Sterility
Class II · Moderate risk
FentaNYL Citrate in 0.9% Sodium Chloride 1 mg per 100 mL
Lack of Assurance of Sterility
Class II · Moderate risk
Difluprednate Ophthalmic Emulsion
Lack of Assurance of Sterility: customer complaint for defective container where breakage of the protective cap exposes tip of eye drop which could compromise sterility.
Class II · Moderate risk
Succinylcholine Chloride Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Anticoagulant Sodium Citrate Solution
Lack of Assurance of Sterility
Class II · Moderate risk
8.4% Sodium Bicarbonate Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Ropivacaine HCl 123 mg
Lack of Assurance of Sterility
Class II · Moderate risk
Rocuronium Bromide Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Phenylephrine HCl Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Phenylephrine HCl Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Phenylephrine HCl Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Oxytocin 30 Units/500 mL
Lack of Assurance of Sterility
Class II · Moderate risk
Neostigmine Methylsulfate Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Neostigmine Methylsulfate Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Neostigmine Methylsulfate Injection
Lack of Assurance of Sterility
Class II · Moderate risk
del Nido Cardioplegia Solution 1000 mL
Lack of Assurance of Sterility
Class II · Moderate risk
Morphine Sulfate Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Morphine Sulfate Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Morphine Sulfate Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Morphine Sulfate Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Lidocaine HCl Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Lidocaine HCl Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Labetalol HCl Injection
Lack of Assurance of Sterility