Class II · Moderate risk
Fluorescein
Lack of Assurance of Sterility
FDA Drug Recalls
1,563 recalls, newest first
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
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
ePHEDrine Sulfate in 0.9% Sodium Chloride
Lack of Assurance of Sterility
Class II · Moderate risk
ePHEDrine Sulfate in 0.9% Sodium Chloride
Lack of Assurance of Sterility
Class II · Moderate risk
ePHEDrine Sulfate in 0.9% Sodium Chloride
Lack of Assurance of Sterility
Class II · Moderate risk
L-Carnitine 27 mL Fill in a 30 mL Vial
Lack of Assurance of Sterility
Class II · Moderate risk
L-Carnitine 27 mL in a 30 mL Vial
Lack of Assurance of Sterility
Class II · Moderate risk
Bimix #3 (Papaverine HCl 30 mg/mL/Phentolamine Mesylate 3 mg/mL)
Lack of Assurance of Sterility
Class II · Moderate risk
Bacteriostatic Water for Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Ascorbic Acid
Lack of Assurance of Sterility
Class II · Moderate risk
Ascorbic Acid
Lack of Assurance of Sterility
Class II · Moderate risk
Alpha Lipoic Acid
Lack of Assurance of Sterility
Class I · High risk
Natpara (parathyroid hormone)
Defective Delivery System: potential risk of rubber stopper particles clogging the needle and leading to underdosing
Class I · High risk
Natpara (parathyroid hormone)
Defective Delivery System: potential risk of rubber stopper particles clogging the needle and leading to underdosing
Class I · High risk
Natpara (parathyroid hormone)
Defective Delivery System: potential risk of rubber stopper particles clogging the needle and leading to underdosing
Class I · High risk
Natpara (parathyroid hormone)
Defective Delivery System: potential risk of rubber stopper particles clogging the needle and leading to underdosing
Class III · Low risk
Zarontin (ethosuximide capsules, USP)
Labeling: Incorrect or Missing Lot and/or Exp Date. The expiry date on the product label is incorrect. The label states an expiry date of 09/2021 when it should be 09/2020.
Class III · Low risk
ethosuximide capsules
Labeling: Incorrect or Missing Lot and/or Exp Date. The expiry date on the product label is incorrect. The label states an expiry date of 09/2021 when it should be 09/2020.
Class II · Moderate risk
Oxcarbazepine Oral Suspension
Failed Impurities/Degradation Specificattion
Class II · Moderate risk
Nucala (mepolizumab)
Temperature Abuse; Product stored and shipped outside of labeled storage requirements.
Class II · Moderate risk
Anagrelide Capsules
Failed Impurities/Degradation Specifications: High Out Of Specification results for impurities detected during routine stability testing.
Class II · Moderate risk
Bacteriostatic Water for Injection
Lack of Assurance of Sterility
Class III · Low risk
Gatifloxacin Ophthalmic Solution 0.5%
Failed Impurities/Degradation Specifications:OOS for unknown impurity.