Class II · Moderate risk
fentaNYL Citrate in 0.9% Sodium Chloride
Lack of Assurance of Sterility
FDA Drug Recalls
1,586 recalls · Class II, 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
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 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 II · Moderate risk
Pantoprazole Sodium Delayed Release Tablets
CGMP Deviation: Presence of dark brown discoloration on edges of tablets.
Class II · Moderate risk
5% Acetyl-L-Cysteine Ophthalmic Solutions
Lack of Processing Controls:
Class II · Moderate risk
10% Acetyl-L-Cysteine Ophthalmic Solutions
Lack of Processing Controls:
Class II · Moderate risk
20% Acetyl-L-Cysteine Ophthalmic Solutions
Lack of Processing Controls:
Class II · Moderate risk
Hydromorphone HCL and Clonidine HCL and Fentanyl Citrate in all strengths
Lack of Processing Controls; Environmental sampling revealed 1 CFU (Colony Forming Unit) identified as Talaromyces rotundus, a fungi.
Class II · Moderate risk
Hydromorphone HCL and Bupivacaine HCL and Baclofen and Clonidine HCL in all strengths
Lack of Processing Controls; Environmental sampling revealed 1 CFU (Colony Forming Unit) identified as Talaromyces rotundus, a fungi.
Class II · Moderate risk
Hydromorphone HCL and Bupivacaine HCL and Baclofen and Clonidine…
Lack of Processing Controls; Environmental sampling revealed 1 CFU (Colony Forming Unit) identified as Talaromyces rotundus, a fungi.
Class II · Moderate risk
Fentanyl Citrate and Clonidine HCL and Morphine Sulfate and Baclofen in all strengths
Lack of Processing Controls; Environmental sampling revealed 1 CFU (Colony Forming Unit) identified as Talaromyces rotundus, a fungi.