Class II · Moderate risk
Sanitizing Hand Spray 80%
GMP Deviations: FDA analysis found product to contain acetaldehyde and acetal above specification limits.
FDA Drug Recalls
1,018 recalls, newest first
Class II · Moderate risk
Lisinopril Tablets USP
Presence of Foreign Substance: Foreign material (metal piece) embedded in one tablet.
Class II · Moderate risk
Skincell Mole & Skin Corrector Serum
Marketed Without An Approved NDA/ANDA; Unapproved new drug
Class II · Moderate risk
Skincell Mole & Skin Corrector Serum
Marketed Without An Approved NDA/ANDA; Unapproved new drug
Class II · Moderate risk
Synergy Hand Sanitizer
CGMP Deviations: FDA analysis found product to contain acetaldehyde impurity and the Sum of All Impurities, above specification limits.
Class II · Moderate risk
Sodium Chloride Ophthalmic Ointment USP
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
Lidocaine Hydrochloride Jelly USP
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
Antibacterial Foaming Wash with Hydria Moisturizing Formula
Labeling: Not Elsewhere Classified - Incorrect label-incorrect scent listed on label.
Class II · Moderate risk
Dextroamphetamine Saccharate
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
ClomiPRAMINE Hydrochloride Capsules
Superpotent Drug: Assay value found to be 110.6% in Chlomipramine Hydrocholoride capsules
Class II · Moderate risk
Neomycin Sulfate Tablets
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
PROPOFOL Injectable Emulsion
Presence of particulate matter
Class II · Moderate risk
Difluprednate Ophthalmic Emulsion
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
Difluprednate Ophthalmic Emulsion
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
Triamcinolone Acetonide Cream USP
CGMP Deviations: Product complaints reporting the product to have a gritty texture and lack of effectiveness.
Class II · Moderate risk
Proton Armor
Chemical Contamination and CGMP Deviations: trace amounts of methanol found in one of the components during the manufacturing process.
Class II · Moderate risk
Proton Armor
Chemical Contamination and CGMP Deviations: trace amounts of methanol found in one of the components during the manufacturing process.
Class II · Moderate risk
Ketorolac Tromethamine Injection
cGMP Deviations: deviations leading to potential cross-contamination.
Class II · Moderate risk
PF-Labetalol HCl Injection
CGMP Deviations: Potential for cross-contamination due to product carryover during manufacturing.
Class II · Moderate risk
PF-0.125% Bupivacaine HCl Injection
CGMP Deviations: Potential for cross-contamination due to product carryover during manufacturing.
Class II · Moderate risk
Trisodium Citrate 0.5% Solution
CGMP Deviations: Potential for cross-contamination due to product carryover during manufacturing.
Class II · Moderate risk
PF-Neostigmine Methylsulfate Injection
CGMP Deviations: Potential for cross-contamination due to product carryover during manufacturing.
Class II · Moderate risk
Corsair Personal Care 99X Instant Foam Hand Sanitizer
CGMP Deviations: Product manufactured using expired active ingredient, Benzalkonium chloride.
Class II · Moderate risk
Maxim Instant Foam Hand Sanitizer
CGMP Deviations: Product manufactured using expired active ingredient, Benzalkonium chloride.
Class III · Low risk
Nighttime Sleep-Aid
Labeling: Not Elsewhere Classified: Carton incorrectly identifies product as doxylamine succinate HCl, however the product is doxylamine succinate.