Class II · Moderate risk Ongoing
Rifampin Capsules
Reason Failed impurities/degradation specifications: Finished product exceeds the 5 ppm interim limit for 1-Methyl-4-Nitrosopoperazine (MNP).
FDA Drug Recalls
14,450 recalls · Class II, newest first
Class II · Moderate risk Ongoing
Rifampin Capsules
Reason Failed impurities/degradation specifications: Finished product exceeds the 5 ppm interim limit for 1-Methyl-4-Nitrosopoperazine (MNP).
Class II · Moderate risk Terminated
Ampicillin for Injection
Reason Presence of Particulate Matter: A complaint was received for the presence of a single strand of hair in one vial.
Class II · Moderate risk Terminated
Neoral soft gelatin capsules
Reason CGMP deviations: Out of specification results obtained during routine stability testing for ethanol content.
Class II · Moderate risk Terminated
Budesonide Inhalation Suspension 0.25mg/2mL
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Lisinopril 10 mg tablets
Reason Presence of Foreign Substance: Foreign material (metal piece) embedded in one tablet.
Class II · Moderate risk Terminated
Sanitizing Hand Spray 80%
Reason GMP Deviations: FDA analysis found product to contain acetaldehyde and acetal above specification limits.
Class II · Moderate risk Terminated
Lisinopril Tablets USP
Reason Presence of Foreign Substance: Foreign material (metal piece) embedded in one tablet.
Class II · Moderate risk Completed
Triamcinolone Acetonide cream
Reason CGMP Deviations: Product complaints reporting the product to have a gritty texture and lack of effectiveness.
Class II · Moderate risk Terminated
Skincell Mole & Skin Corrector Serum
Reason Marketed Without An Approved NDA/ANDA; Unapproved new drug
Class II · Moderate risk Terminated
Skincell Mole & Skin Corrector Serum
Reason Marketed Without An Approved NDA/ANDA; Unapproved new drug
Class II · Moderate risk Terminated
Synergy Hand Sanitizer
Reason CGMP Deviations: FDA analysis found product to contain acetaldehyde impurity and the Sum of All Impurities, above specification limits.
Class II · Moderate risk Terminated
Sodium Chloride Ophthalmic Ointment USP
Reason cGMP Deviations: Turbidity discovered in Artificial Tears Ointment during sterility testing. Scope expanded to include other lots and products which potentially share the same root cause.
Class II · Moderate risk Terminated
Lidocaine Hydrochloride Jelly USP
Reason cGMP Deviations: Turbidity discovered in Artificial Tears Ointment during sterility testing. Scope expanded to include other lots and products which potentially share the same root cause.
Class II · Moderate risk Terminated
Dextroamphetamine Saccharate
Reason Labeling: Label Error on Declared Strength; A sealed 100-count bottle labeled with 15 mg actually contained 100 tablets of 20 mg strength of the drug product.
Class II · Moderate risk Completed
QUAD-MIX 30MG/3MG/60MCG/0.2 Injectable
Reason Lack of Assurance of Sterility
Class II · Moderate risk Completed
QUAD-MIX 30/2/60/0.15 Injectable
Reason Lack of Assurance of Sterility
Class II · Moderate risk Completed
TRI-MIX 50/2.5/25 Injectable
Reason Lack of Assurance of Sterility
Class II · Moderate risk Completed
TRI-MIX 30/2/40 Injectable
Reason Lack of Assurance of Sterility
Class II · Moderate risk Completed
TRI-MIX 30/2/20 Injectable
Reason Lack of Assurance of Sterility
Class II · Moderate risk Completed
TRI-MIX 30/1/60 Injectable
Reason Lack of Assurance of Sterility
Class II · Moderate risk Completed
TRI-MIX 30/1/40 Injectable
Reason Lack of Assurance of Sterility
Class II · Moderate risk Completed
TRI-MIX 30/1/20 Injectable
Reason Lack of Assurance of Sterility
Class II · Moderate risk Completed
TRI-MIX 30/1/10 Injectable
Reason Lack of Assurance of Sterility
Class II · Moderate risk Completed
Test Cyp/Prop
Reason Lack of Assurance of Sterility