Class II · Moderate risk
Ceftriaxone 1 gram Add-Vantage in a) 50 mL and b) 100 mL 0.45% NS bags
Lack of Sterility Assurance
FDA Drug Recalls
11,818 recalls · Class II, newest first
Class II · Moderate risk
Cefazolin 6 grams in 292 mL 0.9% NS bags
Lack of Sterility Assurance
Class II · Moderate risk
Ascorbic Acid 500 mg
Lack of Sterility Assurance
Class II · Moderate risk
70% Ethanol-lock Solution
Lack of Sterility Assurance
Class II · Moderate risk
1/2 Normal Saline 2000 mL + Sodium Acetate 80 mEq.
Lack of Sterility Assurance.
Class II · Moderate risk
0.9% Sodium Chloride a) 500 mL b) 2000 mL and c) 3000 mL bags
Lack of Sterility Assurance
Class II · Moderate risk
Oxycodone Hydrochloride Oral Solution
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
Brevibloc DOUBLE STRENGTH Premixed Injection
Discoloration: presence of atypical yellow discoloration of the solution .
Class II · Moderate risk
Good Neighbor Pharmacy PEG-Phen Lubricant Eye Drops
Presence of Particulate Matter
Class II · Moderate risk
Cisatracurium Besylate Injection
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
Better Braids Un-Braid
Microbial Contamination of Non-Sterile Products: Failed S.aureus test.
Class II · Moderate risk
Ondansetron Tablets USP
Failed Impurities/Degradation Specifications; 12 month stability time point
Class II · Moderate risk
All Malarone
Lack of Processing Controls
Class II · Moderate risk
All potassium bromide Products
Lack of Processing Controls
Class II · Moderate risk
All baclofen Products
Lack of Processing Controls
Class II · Moderate risk
All diethylstilbestrol Products
Lack of Processing Controls
Class II · Moderate risk
All e2-e3-p4 Products
Lack of Processing Controls
Class II · Moderate risk
All tacrolimus Products
Lack of Processing Controls
Class II · Moderate risk
All Nitro Paste
Lack of Processing Controls
Class II · Moderate risk
All hydroquinone Products
Lack of Processing Controls
Class II · Moderate risk
All clobetasol Products
Lack of Processing Controls
Class II · Moderate risk
All methyltestosterone Products
Lack of Processing Controls
Class II · Moderate risk
All ketamine and amitriptyline Products
Lack of Processing Controls
Class II · Moderate risk
All estradiol Products
Lack of Processing Controls
Class II · Moderate risk
All dyclonine Products
Lack of Processing Controls