Class II · Moderate risk
Estradiol Valerate 5mg/Ml Mdv Inj
Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns
FDA Drug Recalls
921 recalls · Class II, newest first
Class II · Moderate risk
Dexpanthenol 250mg/Ml Inj Soln
Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns
Class II · Moderate risk
Cyclosporine 2% Mct Oil Susp
Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns
Class II · Moderate risk
Cyclosporin 0.2% Oil Opth Susp
Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns
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
Pi yen chin Ophthalmic Redness Reliever Drops Made in China
Labeling: Not Elsewhere Classified; The packaging states these are ophthalmic drops. However, they are manufactured as nasal drops and sterility cannot be assured.
Class II · Moderate risk
Naproxen Sodum Tablets USP 220 mg
CGMP Deviations
Class II · Moderate risk
Sodium Bicarbonate in 5% Dextrose Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Carbamazepine 200mg Tablets
Failed Dissolution Specifications
Class II · Moderate risk
Micafungin for Injection
Labeling; Incorrect or Missing Package Insert: The package insert provided with the product does not include all required sections approved for this product. This includes aspects of Adverse Reactions, Drug Interactions and Use in Specific Populations.
Class II · Moderate risk
Micafungin for Injection
Labeling; Incorrect or Missing Package Insert: The package insert provided with the product does not include all required sections approved for this product. This includes aspects of Adverse Reactions, Drug Interactions and Use in Specific Populations.
Class II · Moderate risk
Fexofenadine Hydrochloride Tablets
Failed Impurities/Degradation Specifications
Class II · Moderate risk
Clopidogrel Tablets
Presence of foreign matter
Class II · Moderate risk
Artificial Tears Ointment
Non-Sterility - OOS sterility testing observed during 12-month controlled room temperature stability testing. The microbiological investigation identified the organism as a member of the Bacillus cereus group.
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
Combipatch
Failed Stability Specifications; out of specification for shear.
Class II · Moderate risk
Combipatch
Failed Stability Specifications; out of specification for shear.
Class II · Moderate risk
Succinylcholine Chloride 100 mg/5 mL
Lack of sterility assurance
Class II · Moderate risk
Entacapone Tablets
Failed Dissolution Specifications
Class II · Moderate risk
Cyclobenzaprine Hydrochloride Tablets
CGMP Deviations: Out of specification (OOS) test result for Total Aerobic Microbial Count (TAMC) and Total Yeast and Mold Count (TYMC) for an excipient batch of Dibasic Calcium Phosphate.