Class II · Moderate risk Terminated
Timolol-Latanoprost
Reason Subpotent Drug: The batches contain less than 90% of the labeled amount of latanoprost.
FDA Drug Recalls
11,815 recalls · Class II, newest first
Class II · Moderate risk Terminated
Moxifloxacin Ophthalmic Solution
Reason cGMP deviation: discontinue of stability support for product.
Class II · Moderate risk Terminated
Carvedilol Tablets
Reason Failed Tablet/Capsule Specifications: Tablets exceeds specification for weight and thickness.
Class II · Moderate risk Terminated
Buprenorphine and Naloxone Sublingual Tablets 8 mg/2 mg
Reason Presence of Foreign Substance
Class II · Moderate risk Terminated
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
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
Fondaparinux Sodium Injection
Reason Subpotent Drug: Out of specification for assay
Class II · Moderate risk Terminated
Pyridostigmine Bromide Oral Solution
Reason cGMP Deviations: Out of specification for assay of one of the preservative ingredients.
Class II · Moderate risk Terminated
Arformoterol Tartrate Inhalation Solution
Reason Lack of Assurance of Sterility: environmental monitoring failure.
Class II · Moderate risk Terminated
Aminophylline Injection
Reason Presence of Particulate Matter: A complaint was received for the presence of a hair in one vial.
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 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 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 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.