Class II · Moderate risk Terminated
Budesonide Inhalation Suspension 0.25mg/2mL
Reason Lack of Assurance of Sterility
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Class II · Moderate risk Terminated
Lisinopril 10 mg tablets
Reason Presence of Foreign Substance: Foreign material (metal piece) embedded in one tablet.
Class I · High risk Terminated
Antica Farmacista Hand Sanitizer Ocean Citron
Reason Chemical Contamination: product found to contain benzene
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 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 III · Low risk Terminated
Antibacterial Foaming Wash with Hydria Moisturizing Formula
Reason Labeling: Not Elsewhere Classified - Incorrect label-incorrect scent listed on label.
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 III · Low risk Terminated
ClomiPRAMINE Hydrochloride Capsules
Reason Superpotent Drug: Assay value found to be 110.6% in Chlomipramine Hydrocholoride capsules
Class II · Moderate risk Terminated
Neomycin Sulfate Tablets
Reason CGMP Deviations: A foreign matter identified as teflon was found in the Active Pharmaceutical Ingredient (API) used in the manufacture of Neomycin Sulfate Tablets, USP 500 mg.
Class I · High risk Terminated
PROPOFOL Injectable Emulsion
Reason Presence of particulate matter
Class II · Moderate risk Terminated
Difluprednate Ophthalmic Emulsion
Reason Lack of Assurance of Sterility: customer complaint for defective container where breakage of the protective cap exposes tip of eye drop which could compromise sterility.
Class II · Moderate risk Terminated
Difluprednate Ophthalmic Emulsion
Reason Lack of Assurance of Sterility: customer complaint for defective container where breakage of the protective cap exposes tip of eye drop which could compromise sterility.
Class II · Moderate risk Terminated
Triamcinolone Acetonide Cream USP
Reason CGMP Deviations: Product complaints reporting the product to have a gritty texture and lack of effectiveness.
Class II · Moderate risk Terminated
Proton Armor
Reason Chemical Contamination and CGMP Deviations: trace amounts of methanol found in one of the components during the manufacturing process.
Class II · Moderate risk Terminated
Proton Armor
Reason Chemical Contamination and CGMP Deviations: trace amounts of methanol found in one of the components during the manufacturing process.
Class II · Moderate risk Terminated
Ketorolac Tromethamine Injection
Reason cGMP Deviations: deviations leading to potential cross-contamination.
Class II · Moderate risk Terminated
PF-Labetalol HCl Injection
Reason CGMP Deviations: Potential for cross-contamination due to product carryover during manufacturing.
Class II · Moderate risk Terminated
PF-0.125% Bupivacaine HCl Injection
Reason CGMP Deviations: Potential for cross-contamination due to product carryover during manufacturing.
Class II · Moderate risk Terminated
Trisodium Citrate 0.5% Solution
Reason CGMP Deviations: Potential for cross-contamination due to product carryover during manufacturing.
Class II · Moderate risk Terminated
PF-Neostigmine Methylsulfate Injection
Reason CGMP Deviations: Potential for cross-contamination due to product carryover during manufacturing.