Class II · Moderate risk Terminated
Rugby Diocto Syrup
Reason Microbial contamination of Non-sterile Products; presence of yeast and potential B. cepacia contamination
FDA Drug Recalls
11,815 recalls · Class II, newest first
Class II · Moderate risk Terminated
Rugby Diocto Liquid
Reason Microbial contamination of Non-sterile Products; presence of yeast and potential B. cepacia contamination
Class II · Moderate risk Terminated
Famotidine USP 20 mg
Reason Failed Tablet/Capsule Specification: out of specification for tablet weight.
Class II · Moderate risk Terminated
0.9% Sodium Chloride Injection
Reason Presence of Particulate Matter; stainless steel
Class II · Moderate risk Terminated
Hydromorphone Hydrochloride Injection
Reason Presence of Particulate Matter: Silicone oil
Class II · Moderate risk Terminated
Hydromorphone Hydrochloride Injection
Reason Presence of Particulate Matter: Silicone oil
Class II · Moderate risk Terminated
Hydromorphone Hydrochloride Injection
Reason Presence of Particulate Matter: Silicone oil
Class II · Moderate risk Terminated
Famotidine Tablets USP
Reason Failed Tablet/Capsule Specification; out of specification for tablet weight
Class II · Moderate risk Terminated
Entecavir Tablets 0.5 mg
Reason Failed Impurities/Degradation Specification: single unknown impurity OOS 0.33% (Limit:NMT 0.20%W/W) at the three month stability point.
Class II · Moderate risk Terminated
Magnesium Citrate Oral Solution
Reason Microbial contamination of non-sterile products: product was found to contain mold, identified as Rhinocladiella similis.
Class II · Moderate risk Terminated
Rocuronium Bromide Injection Solution 5 mL
Reason Lack of Sterility Assurance.
Class II · Moderate risk Terminated
Neostigmine Methylsulfate Injection Solution 5 mL
Reason Lack of Sterility Assurance.
Class II · Moderate risk Terminated
Adenosine in 0.9% Sodium Chloride 30mL
Reason Lack of Sterility Assurance.
Class II · Moderate risk Terminated
Sodium Bicarbonate 8.4% Injection Solution 50 mL
Reason Lack of Sterility Assurance.
Class II · Moderate risk Terminated
Phenylephrine HCL in 0.9% Sodium Chloride 10 mL
Reason Lack of Sterility Assurance.
Class II · Moderate risk Terminated
Diltiazem HCl 125 mg in 5% Dextrose 125 mL Single-Dose- Bag
Reason Lack of Sterility Assurance.
Class II · Moderate risk Terminated
Norepinephrine Bitartrate 4 mg Added to 0.9% Sodium Chloride 250 mL
Reason Lack of Sterility Assurance.
Class II · Moderate risk Terminated
Norepinephrine Bitartrate 16 mg Added to 0.9% Sodium Chloride 250 mL
Reason Lack of Sterility Assurance.
Class II · Moderate risk Terminated
Norepinephrine Bitartrate 8 mg Added to 0.9% Sodium Chloride 250 mL
Reason Lack of Sterility Assurance.
Class II · Moderate risk Terminated
Succinylcholine Chloride Injection Solution 5 mL
Reason Lack of Sterility Assurance.
Class II · Moderate risk Terminated
Succinylcholine Chloride Injection Solution 10 mL
Reason Lack of Sterility Assurance.
Class II · Moderate risk Terminated
Glycopyrrolate Injection Solution
Reason Lack of Sterility Assurance.
Class II · Moderate risk Terminated
Glycopyrrolate Injection Solution
Reason Lack of Sterility Assurance.
Class II · Moderate risk Terminated
Glycopyrrolate Injection Solution
Reason Lack of Sterility Assurance.
Class II · Moderate risk Terminated
Ephedrine Sulfate in 0.9% Sodium Chloride 5 mL
Reason Lack of Sterility Assurance.