Class II · Moderate risk
Cyclosporin 0.2% Oil Opth Susp
Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns
FDA Drug Recalls
5,405 recalls, newest first
Class II · Moderate risk
Ascorbic/Glutathione 1.25/1.25% Opth Soln
Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns
Class II · Moderate risk
Ascorbic Acid
Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns
Class II · Moderate risk
Ascorbic Acid
Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns
Class II · Moderate risk
Levocarnitine 100mg/Ml Mdv Soln
Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns
Class II · Moderate risk
Magnesium Chloride
Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns
Class II · Moderate risk
Calcium Chloride
Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns
Class II · Moderate risk
Sodium Bicarbonate in 5% Dextrose Injection
Lack of Assurance of Sterility
Class I · High risk
Sodium Bicarbonate in 5% Dextrose Injection
Non-Sterility: firm's third party lab confirmed microbial contamination.
Class II · Moderate risk
Fludarabine Phosphate for Injection
Lack of Assurance of Sterility: the manufacturing firm had microbial recoveries during environmental monitoring in aseptic areas of manufacturing.
Class II · Moderate risk
Succinylcholine Chloride 100 mg/5 mL
Lack of sterility assurance
Class II · Moderate risk
Adenosine Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Leucovorin Calcium for Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Leucovorin Calcium for Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Octreotide Acetate Injection 50 mcg/mL
Lack of Assurance of Sterility
Class II · Moderate risk
Octreotide Acetate Injection 100 mcg/mL
Lack of Assurance of Sterility
Class II · Moderate risk
Methylprednisolone Acetate Injectable Suspension USP
Lack of Assurance of Sterility
Class II · Moderate risk
Alprostadil Injection USP
Lack of Assurance of Sterility
Class II · Moderate risk
Metoclopramide Injection USP
Lack of Assurance of Sterility
Class II · Moderate risk
Adenosine Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Norepinephrine Bitartrate Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Epoprostenol Sodium for Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Leucovorin Calcium for Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Octreotide Acetate Injection 1000 mcg/5mL
Lack of Assurance of Sterility
Class II · Moderate risk
Vecuronium Bromide for Injection 10 mg
Lack of Assurance of Sterility