Class II · Moderate risk
LL Bioboost Injectable
Lack of Assurance of Sterility
FDA Drug Recalls
692 recalls, newest first
Class II · Moderate risk
CJC-1295 Injectable
Lack of Assurance of Sterility
Class II · Moderate risk
Methylcobalamin Injectable
Lack of Assurance of Sterility
Class II · Moderate risk
BD ChloraPrep Clear
Lack of Assurance of Sterility: The affected product may exhibit an open seal on the packaging of the applicator.
Class II · Moderate risk
Testosterone Cypionate Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Polyvinyl Alcohol Ophthalmic Solution 1.4%
cGMP deviations and lack of assurance of sterility.
Class II · Moderate risk
Lubricant Eye Drops Solution
cGMP deviations and lack of assurance of sterility.
Class II · Moderate risk
Carboxymethylcellulose Sodium Ophthalmic Solution 0.5%
cGMP deviations and lack of assurance of sterility.
Class II · Moderate risk
Carboxymethylcellulose Sodium Ophthalmic Gel 1%
cGMP deviations and lack of assurance of sterility.
Class II · Moderate risk
Artificial Tears Ophthalmic Solution
cGMP deviations and lack of assurance of sterility.
Class II · Moderate risk
niCARdipine Hydrochloride Injection
Lack of sterility assurance: Product leakage around the vial neck, which could potentially result in a lack of sterility assurance.
Class II · Moderate risk
niCARdipine Hydrochloride Injection
Lack of sterility assurance: Product leakage around the vial neck, which could potentially result in a lack of sterility assurance.
Class II · Moderate risk
FentaNYL 500mcg
Lack of Assurance of Sterility
Class II · Moderate risk
Rocuronium Bromide 50 mg per 5mL
Lack of Assurance of Sterility: Leaking/damaged syringes.
Class II · Moderate risk
Ketamine HCl 50mg per 5mL
Lack of Assurance of Sterility: Leaking/damaged syringes.
Class II · Moderate risk
PHENYLephrine HCl in 0.9% Sodium Chloride
Lack of Assurance of Sterility: Leaking/damaged syringes.
Class II · Moderate risk
dexmedeTOMIDine HCl PF
Lack of Assurance of Sterility: Leaking/damaged syringes.
Class II · Moderate risk
Glycopyrrolate
Lack of Assurance of Sterility: Leaking/damaged syringes.
Class II · Moderate risk
Haloperidol Decanoate Injection
Lack of Assurance of Sterility: Media fill with bacterial contamination
Class II · Moderate risk
Haloperidol Decanoate Injection 100mg/mL
Lack of Assurance of Sterility: Media fill with bacterial contamination
Class II · Moderate risk
Haloperidol Decanoate Injection 50mg/mL
Lack of Assurance of Sterility: Media fill with bacterial contamination
Class II · Moderate risk
Haloperidol Decanoate Injection 50mg/mL
Lack of Assurance of Sterility: Media fill with bacterial contamination
Class II · Moderate risk
Methocarbamol Injection USP 1
Lack of Assurance of Sterility: Media fill with bacterial contamination
Class II · Moderate risk
8.4% Sodium Bicarbonate Injection
Lack of Assurance of Sterility
Class II · Moderate risk
fentaNYL Citrate PF 200 mcg/100 mL
Lack of Assurance of Sterility