Class II · Moderate risk Terminated
70% Ethanol-lock Solution
Reason Lack of Sterility Assurance
FDA Drug Recalls
11,815 recalls · Class II, newest first
Class II · Moderate risk Terminated
1/2 Normal Saline 2000 mL + Sodium Acetate 80 mEq.
Reason Lack of Sterility Assurance.
Class II · Moderate risk Terminated
0.9% Sodium Chloride a) 500 mL b) 2000 mL and c) 3000 mL bags
Reason Lack of Sterility Assurance
Class II · Moderate risk Terminated
Oxycodone Hydrochloride Oral Solution
Reason Defective Container: Excess lidding material accumulation between the seal and the cup resulting in the lid not properly adhering and allowing leakage.
Class II · Moderate risk Terminated
Brevibloc DOUBLE STRENGTH Premixed Injection
Reason Discoloration: presence of atypical yellow discoloration of the solution .
Class II · Moderate risk Terminated
Good Neighbor Pharmacy PEG-Phen Lubricant Eye Drops
Reason Presence of Particulate Matter
Class II · Moderate risk Terminated
Cisatracurium Besylate Injection
Reason Incorrect/ Undeclared Excipient: Firm is recalling product due to an incorrect statement of Preservative free on the individual carton label. The vial label and outer carton label contain the correct statement of 0.9% benzyl alcohol added as a preservative.
Class II · Moderate risk Terminated
Better Braids Un-Braid
Reason Microbial Contamination of Non-Sterile Products: Failed S.aureus test.
Class II · Moderate risk Terminated
Ondansetron Tablets USP
Reason Failed Impurities/Degradation Specifications; 12 month stability time point
Class II · Moderate risk Terminated
All Malarone
Reason Lack of Processing Controls
Class II · Moderate risk Terminated
All potassium bromide Products
Reason Lack of Processing Controls
Class II · Moderate risk Terminated
All baclofen Products
Reason Lack of Processing Controls
Class II · Moderate risk Terminated
All diethylstilbestrol Products
Reason Lack of Processing Controls
Class II · Moderate risk Terminated
All e2-e3-p4 Products
Reason Lack of Processing Controls
Class II · Moderate risk Terminated
All tacrolimus Products
Reason Lack of Processing Controls
Class II · Moderate risk Terminated
All Nitro Paste
Reason Lack of Processing Controls
Class II · Moderate risk Terminated
All hydroquinone Products
Reason Lack of Processing Controls
Class II · Moderate risk Terminated
All clobetasol Products
Reason Lack of Processing Controls
Class II · Moderate risk Terminated
All methyltestosterone Products
Reason Lack of Processing Controls
Class II · Moderate risk Terminated
All ketamine and amitriptyline Products
Reason Lack of Processing Controls
Class II · Moderate risk Terminated
All estradiol Products
Reason Lack of Processing Controls
Class II · Moderate risk Terminated
All dyclonine Products
Reason Lack of Processing Controls
Class II · Moderate risk Terminated
All doxycycline Products
Reason Lack of Processing Controls
Class II · Moderate risk Terminated
All sucralfate Products
Reason Lack of Processing Controls
Class II · Moderate risk Terminated
All fluconazole Products
Reason Lack of Processing Controls