Class II · Moderate risk Ongoing
0.9% Sodium Chloride Injection USP
Reason Lack of assurance of sterility: pinholes, within the finger boxes used during Form Fill Seal process resulting in leaks.
FDA Drug Recalls
2,277 recalls · Class II, newest first
Class II · Moderate risk Ongoing
Kimmtrak
Reason Subpotent Drug
Class II · Moderate risk Ongoing
LIDOcaine HCL Sterile Injection
Reason Lack of Assurance of Sterility: A recent FDA inspection revealed concerns with the sterile manufacturing process.
Class II · Moderate risk Ongoing
LIDOcaine HCL Sterile Injection
Reason Lack of Assurance of Sterility: A recent FDA inspection revealed concerns with the sterile manufacturing process.
Class II · Moderate risk Ongoing
KETAmine Hydrochloride Injection
Reason Lack of Assurance of Sterility: A recent FDA inspection revealed concerns with the sterile manufacturing process.
Class II · Moderate risk Ongoing
KETAmine Hydrochloride Injection
Reason Lack of Assurance of Sterility: A recent FDA inspection revealed concerns with the sterile manufacturing process.
Class II · Moderate risk Ongoing
BUPIVAcaine HCL Sterile injection
Reason Lack of Assurance of Sterility: A recent FDA inspection revealed concerns with the sterile manufacturing process.
Class II · Moderate risk Ongoing
LIDOcaine HCl Injection
Reason Lack of Assurance of Sterility: A recent FDA inspection revealed concerns with the sterile manufacturing process.
Class II · Moderate risk Ongoing
Testo-200
Reason Marketed Without an Approved NDA/ANDA
Class II · Moderate risk Ongoing
Icosapent Ethyl Capsules 1 gram
Reason Failed Tablet/Capsule specifications; a product complaint was reported for burnt or melted capsules. This was determined to be a result of oxidation by leakage of capsule contents.
Class II · Moderate risk Ongoing
Gentamicin Injection
Reason Failed Stability Specifications: Out of specification results for the Color Absorbance test during 12 Month sample analysis.
Class II · Moderate risk Ongoing
Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
Azelastine HCl Ophthalmic Solution
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
Ketorolac Tromethamine Ophthalmic Solution
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
DOBUTamine Injection
Reason Discoloration; discolored solution from cracked vials
Class II · Moderate risk Ongoing
Lacosamide Oral Solution
Reason Defective Container: This recall is being initiated due to a leaking unit stored horizontally.
Class II · Moderate risk Ongoing
0.9% Sodium Chloride Injection
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
Metoclopramide Tablets
Reason Presence of foreign tablets/capsules.
Class II · Moderate risk Ongoing
Cephalexin for Oral Suspension
Reason Failed Impurities/Degradation Specifications An out-of-specification result was observed in the related substance test at the sixth month of stability analysis. The individual impurity was identified to be Cephalexin Glucose Adduct.
Class II · Moderate risk Ongoing
Cephalexin for Oral Suspension
Reason Failed Impurities/Degradation Specifications An out-of-specification result was observed in the related substance test at the sixth month of stability analysis. The individual impurity was identified to be Cephalexin Glucose Adduct.
Class II · Moderate risk Ongoing
Spectrum Advanced Gel Hand Sanitizer
Reason Subpotent product: Product has cloudy appearance and tested below assay label claim for 70% Ethyl Alcohol
Class II · Moderate risk Ongoing
Acetaminophen Tablets
Reason cGMP deviations: Due to confirmed consumer complaints received with the observation of tablet discoloration (brown surface on tablets).
Class II · Moderate risk Ongoing
Nicotinamide adenine dinucleotide
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
Tirzepatide/Cyanocobalamin Injectable
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
Tirzepatide/Cyanocobalamin Injectable
Reason Lack of Assurance of Sterility