Class II · Moderate risk
Phenylephrine 2.5% + Tropicamide 1% Compounded Eye Drops Solution
Lack of Sterility Assurance
FDA Drug Recalls
635 recalls, newest first
Class II · Moderate risk
AMGEN Kyprolis
Lack of Assurance of Sterility: Potential cracks in glass vials
Class I · High risk
Nano PNC Water
Marketed without an Approved NDA/ANDA and non-sterility: NANO PNC Water by nebulizer was sampled and found to contain variovorax paradoxus.
Class II · Moderate risk
Fluconazole Injection
Lack of Assurance of Sterility: confirmed customer complaints of leaking bags.
Class II · Moderate risk
Succinylcholine Chloride 200 mg/10 mL Injection Solution 10 mL
Lack of Assurance of Sterility - the firm is recalling select sterile drug products.
Class II · Moderate risk
Ropivacaine HCl 0.25% in 0.9% Sodium Chloride
Lack of Assurance of Sterility - the firm is recalling select sterile drug products.
Class II · Moderate risk
Rocuronium Bromide 50 mg/5 mL Injection Solution
Lack of Assurance of Sterility - the firm is recalling select sterile drug products.
Class II · Moderate risk
Oxytocin 30 USP Units Added to 0.9% Sodium Chloride
Lack of Assurance of Sterility - the firm is recalling select sterile drug products.
Class II · Moderate risk
Neostigmine Methylsulfate 5 mg/5 mL Injection Solution
Lack of Assurance of Sterility - the firm is recalling select sterile drug products.
Class II · Moderate risk
Morphine Sulfate 1 mg/mL in 0.9% Sodium Chloride
Lack of Assurance of Sterility - the firm is recalling select sterile drug products.
Class II · Moderate risk
Midazolam HCl 50 mg/50 mL in 0.9% Sodium Chloride
Lack of Assurance of Sterility - the firm is recalling select sterile drug products.
Class II · Moderate risk
Lidocaine HCl 1%
Lack of Assurance of Sterility - the firm is recalling select sterile drug products.
Class II · Moderate risk
Hydromorphone HCl 1 mg/mL in 0.9% Sodium Chloride 30 mL PCA Vial
Lack of Assurance of Sterility - the firm is recalling select sterile drug products.
Class II · Moderate risk
HYDROmorphone HCl 50 mg/50 mL in 0.9% Sodium Chloride
Lack of Assurance of Sterility - the firm is recalling select sterile drug products.
Class II · Moderate risk
HYDROmorphone HCl 6 mg/30 mL in 0.9% Sodium Chloride
Lack of Assurance of Sterility - the firm is recalling select sterile drug products.
Class II · Moderate risk
Heparin Sodium 5
Lack of Assurance of Sterility - the firm is recalling select sterile drug products.
Class II · Moderate risk
Heparin Sodium
Lack of Assurance of Sterility - the firm is recalling select sterile drug products.
Class II · Moderate risk
Glycopyrrolate 1 mg/5 mL
Lack of Assurance of Sterility - the firm is recalling select sterile drug products.
Class II · Moderate risk
Fentanyl Citrate 2 mcg/mL & Bupivacaine HCl 0.125% in 0.9% Sodium Chloride
Lack of Assurance of Sterility - the firm is recalling select sterile drug products.
Class II · Moderate risk
Fentanyl Citrate 2
Lack of Assurance of Sterility - the firm is recalling select sterile drug products.
Class II · Moderate risk
Fentanyl Citrate 1
Lack of Assurance of Sterility - the firm is recalling select sterile drug products.
Class II · Moderate risk
Calcium Chloride
Lack of Assurance of Sterility - the firm is recalling select sterile drug products.
Class II · Moderate risk
Calcium Chloride
Lack of Assurance of Sterility - the firm is recalling select sterile drug products.
Class II · Moderate risk
Phenylephrine HCl 1 mg/10 mL
Lack of Assurance of Sterility - the firm is recalling select sterile drug products.
Class II · Moderate risk
Calcium Chloride 1 g/50 mL* Added to 5% Dextrose
Lack of Assurance of Sterility - the firm is recalling select sterile drug products.