Class II · Moderate risk Terminated
fentaNYL Citrate in 0.9% Sodium Chloride
Reason Lack of Assurance of Sterility
FDA Drug Recalls
14,450 recalls · Class II, newest first
Class II · Moderate risk Terminated
fentaNYL Citrate in 0.9% Sodium Chloride
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
fentaNYL Citrate in 0.9% Sodium Chloride
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
ePHEDrine Sulfate in 0.9% Sodium Chloride
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
ePHEDrine Sulfate in 0.9% Sodium Chloride
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
ePHEDrine Sulfate in 0.9% Sodium Chloride
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
L-Carnitine 27 mL Fill in a 30 mL Vial
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
L-Carnitine 27 mL in a 30 mL Vial
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Bimix #3
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Bacteriostatic Water for Injection
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Ascorbic Acid
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Ascorbic Acid
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Alpha Lipoic Acid
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Oxcarbazepine Oral Suspension
Reason Failed Impurities/Degradation Specificattion
Class II · Moderate risk Terminated
Nucala
Reason Temperature Abuse; Product stored and shipped outside of labeled storage requirements.
Class II · Moderate risk Terminated
Anagrelide Capsules
Reason Failed Impurities/Degradation Specifications: High Out Of Specification results for impurities detected during routine stability testing.
Class II · Moderate risk Terminated
Bacteriostatic Water for Injection
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Pantoprazole Sodium Delayed Release Tablets
Reason CGMP Deviation: Presence of dark brown discoloration on edges of tablets.
Class II · Moderate risk Terminated
5% Acetyl-L-Cysteine Ophthalmic Solutions
Reason Lack of Processing Controls:
Class II · Moderate risk Terminated
10% Acetyl-L-Cysteine Ophthalmic Solutions
Reason Lack of Processing Controls:
Class II · Moderate risk Terminated
20% Acetyl-L-Cysteine Ophthalmic Solutions
Reason Lack of Processing Controls:
Class II · Moderate risk Terminated
Hydromorphone HCL and Clonidine HCL and Fentanyl Citrate in all strengths
Reason Lack of Processing Controls; Environmental sampling revealed 1 CFU (Colony Forming Unit) identified as Talaromyces rotundus, a fungi.
Class II · Moderate risk Terminated
Hydromorphone HCL and Bupivacaine HCL and Baclofen and Clonidine…
Reason Lack of Processing Controls; Environmental sampling revealed 1 CFU (Colony Forming Unit) identified as Talaromyces rotundus, a fungi.
Class II · Moderate risk Terminated
Hydromorphone HCL and Bupivacaine HCL and Baclofen and Clonidine…
Reason Lack of Processing Controls; Environmental sampling revealed 1 CFU (Colony Forming Unit) identified as Talaromyces rotundus, a fungi.
Class II · Moderate risk Terminated
Fentanyl Citrate and Clonidine HCL and Morphine Sulfate and…
Reason Lack of Processing Controls; Environmental sampling revealed 1 CFU (Colony Forming Unit) identified as Talaromyces rotundus, a fungi.