Class II · Moderate risk
Biotin Suspension 10mg/mL
Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method of sterilization.
FDA Drug Recalls
6,161 recalls · Class II, newest first
Class II · Moderate risk
B-complex (B1-200mg, B2-4mg, B3-200mg,B5-4mg,B6-4mg)
Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method of sterilization.
Class II · Moderate risk
Ascorbic Acid
Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method of sterilization.
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 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.