Class II · Moderate risk Terminated
Ascorbic/Glutathione 1.25/1.25% Opth Soln
Reason Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns
FDA Drug Recalls
14,450 recalls · Class II, newest first
Class II · Moderate risk Terminated
Ascorbic Acid
Reason Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns
Class II · Moderate risk Terminated
Ascorbic Acid
Reason Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns
Class II · Moderate risk Terminated
Levocarnitine 100mg/Ml Mdv Soln
Reason Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns
Class II · Moderate risk Terminated
Magnesium Chloride
Reason Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns
Class II · Moderate risk Terminated
Calcium Chloride
Reason Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns
Class II · Moderate risk Terminated
Pi yen chin Ophthalmic Redness Reliever Drops Made in China
Reason 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 Terminated
Naproxen Sodum Tablets USP 220 mg
Reason CGMP Deviations
Class II · Moderate risk Terminated
Sodium Bicarbonate in 5% Dextrose Injection
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Carbamazepine 200mg Tablets
Reason Failed Dissolution Specifications
Class II · Moderate risk Terminated
Micafungin for Injection
Reason 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 Terminated
Micafungin for Injection
Reason 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 Terminated
Fexofenadine Hydrochloride Tablets
Reason Failed Impurities/Degradation Specifications
Class II · Moderate risk Terminated
Clopidogrel Tablets
Reason Presence of foreign matter
Class II · Moderate risk Terminated
Artificial Tears Ointment
Reason 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 Terminated
Fludarabine Phosphate for Injection
Reason Lack of Assurance of Sterility: the manufacturing firm had microbial recoveries during environmental monitoring in aseptic areas of manufacturing.
Class II · Moderate risk Ongoing
Combipatch
Reason Failed Stability Specifications; out of specification for shear.
Class II · Moderate risk Ongoing
Combipatch
Reason Failed Stability Specifications; out of specification for shear.
Class II · Moderate risk Terminated
Succinylcholine Chloride 100 mg/5 mL
Reason Lack of sterility assurance
Class II · Moderate risk Terminated
Entacapone Tablets
Reason Failed Dissolution Specifications
Class II · Moderate risk Terminated
Cyclobenzaprine Hydrochloride Tablets
Reason 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.
Class II · Moderate risk Terminated
Cyclobenzaprine Hydrochloride Tablets
Reason 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.
Class II · Moderate risk Terminated
Cyclobenzaprine Hydrochloride Tablets
Reason 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.
Class II · Moderate risk Ongoing
Erythromycin Topical Solution USP
Reason Defective container: possibility for lack of seal integrity.
Class II · Moderate risk Terminated
Adenosine Injection
Reason Lack of Assurance of Sterility