Class II · Moderate risk
Ganciclovir for Injection
Labeling: Label mix-up - one vial was mislabeled as Cladribine Injection 10mg/mL inside a 10-count carton of Ganciclovir 500 mg.
FDA Drug Recalls
943 recalls · Class II, newest first
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 II · Moderate risk
Luxury 70% Isopropyl Alcohol
Labeling: Product Contains Undeclared API - product contains undeclared ethyl alcohol
Class II · Moderate risk
Luxury 70% Isopropyl Alcohol
Labeling: Product Contains Undeclared API - product contains undeclared ethyl alcohol
Class II · Moderate risk
Alcohol Swabsticks
CGMP Deviations: products were stored outside the drug label specifications.
Class II · Moderate risk
Sterile Alcohol Prep Pads
CGMP Deviations: products were stored outside the drug label specifications.
Class II · Moderate risk
Racepinephrine Inhalation Solution
CGMP Deviations: products were stored outside the drug label specifications.
Class II · Moderate risk
Asthmanefrin Racephinephrine Inhalation Solution Bronchodilator
CGMP Deviations: products were stored outside the drug label specifications.
Class II · Moderate risk
Dakin's Solution
CGMP Deviations: products were stored outside the drug label specifications.
Class II · Moderate risk
A&D Original Ointment
CGMP Deviations: products were stored outside the drug label specifications.
Class II · Moderate risk
Pataday
CGMP Deviations: products were stored outside the drug label specifications.
Class II · Moderate risk
GenTeal Tears
CGMP Deviations: products were stored outside the drug label specifications.
Class II · Moderate risk
Miralax (Polyethylene Glycol 3350)
CGMP Deviations: products were stored outside the drug label specifications.
Class II · Moderate risk
Debrox
CGMP Deviations: products were stored outside the drug label specifications.
Class II · Moderate risk
Systane Zaditor
CGMP Deviations: products were stored outside the drug label specifications.
Class II · Moderate risk
Systane Balance
CGMP Deviations: products were stored outside the drug label specifications.
Class II · Moderate risk
Eye-stream
CGMP Deviations: products were stored outside the drug label specifications.
Class II · Moderate risk
Systane
CGMP Deviations: products were stored outside the drug label specifications.
Class II · Moderate risk
Naphcon A eye drops
CGMP Deviations: products were stored outside the drug label specifications.
Class II · Moderate risk
Bisacodyl Suppositories
CGMP Deviations: products were stored outside the drug label specifications.
Class II · Moderate risk
Triple Antibiotic Ointment
CGMP Deviations: products were stored outside the drug label specifications.
Class II · Moderate risk
Hydrogen Peroxide Topical Solution
Labeling: Label Mix-Up-The primary label on the front of the bottles have Hydrogen Peroxide affixed to the front and back of the containers. However, the product inside the bottle is 70% Isopropyl Alcohol.
Class II · Moderate risk
The Natural Dentist Healthy Breath Antiseptic Rinse
Labeling; Label mix-up and Wrong Bar Code; back label incorrectly states active ingredient as Peppermint Oil and Sage Oil and has the wrong UPC
Class II · Moderate risk
Sucralfate Oral Suspension
Labeling: Label Mix-Up
Class II · Moderate risk
HEB 50% Isopropyl Alcohol First Aid Antiseptic
Labeling: Label Mix-Up-The primary label on the front of the bottles have 50% Isopropyl Alcohol affixed to the containers. However, the product inside the bottle is Hydrogen Peroxide, Topical Solution USP with active ingredient Hydrogen Peroxide (stabilized) 3%, 32 FL Ounces. The back label is correct. Product is packaged in dark bottles.