Class III · Low risk
Isopto Carpine
Failed Impurities/Degradation Specifications.
FDA Drug Recalls
1,525 recalls · Class III, newest first
Class III · Low risk
CLENZIderm M.D. Acne Treatment System
Discoloration.
Class III · Low risk
Class III · Low risk
Ciclopirox Olamine Cream USP
Labeling: Incorrect or Missing Package Insert: product lots packaged with an out-of-date insert.
Class III · Low risk
Fluocinonide Cream UPS
Cross contamination with other products: Certain lots of Fluocinonide Cream were found to be contaminated with a small quantity of hydrocortisone-17-valerate.
Class III · Low risk
Lumigan (bimatoprost ophthalmic solution)
Failed Impurities/Degradation Specifications
Class III · Low risk
Fluphenazine Decanoate Injection
Subpotent Drug
Class III · Low risk
Adalat CC (nifedipine)
Cross Contamination with another product:residual powder found in inlet air duct identified as sorafenib
Class III · Low risk
Adalat CC (nifedipine)
Cross Contamination with another product:residual powder found in inlet air duct identified as sorafenib
Class III · Low risk
Adalat CC (nifedipine)
Cross Contamination with another product:residual powder found in inlet air duct identified as sorafenib
Class III · Low risk
Adalat CC (nifedipine)
Cross Contamination with another product:residual powder found in inlet air duct identified as sorafenib
Class III · Low risk
Nifedipine Extended-Release Tablets
Cross Contamination with another product:residual powder found in inlet air duct identified as sorafenib
Class III · Low risk
Nifedipine Extended-Release Tablets
Cross Contamination with another product:residual powder found in inlet air duct identified as sorafenib
Class III · Low risk
Adalat CC (nifedipine)
Cross Contamination with another product:residual powder found in inlet air duct identified as sorafenib
Class III · Low risk
Adalat CC (nifedipine)
Cross Contamination with another product:residual powder found in inlet air duct identified as sorafenib
Class III · Low risk
Nifedipine Extended-Release Tablets
Cross Contamination with another product:residual powder found in inlet air duct identified as sorafenib
Class III · Low risk
Quillivant XR
Failed Dissolution Specifications: Dissolution at 8 hour was out of specification at 12 month at 25 degree Celsius.
Class III · Low risk
Quillivant XR
Failed Dissolution Specifications: Dissolution at 8 hour was out of specification at 12 month at 25 degree Celsius.
Class III · Low risk
Quillivant XR
Failed Dissolution Specifications: Dissolution at 8 hour was out of specification at 12 month at 25 degree Celsius.
Class III · Low risk
Indian God Lotion Spray Bottle
Marked Without An Approved NDA/ANDA: FDA analysis found this product to contain diethyl phthalate, an inactive ingredient in several modified release solid oral dosage forms, making this product unapproved drug for which safety and efficacy have not been establish and therefore, subject to recall.
Class III · Low risk
RIVASTIGMINE Tartrate Capsules
Cross-contamination with other products -Related Substances test for Rivastigmine Tartrate Capsules USP, 1.5 mg showed a peak for Ranitidine.
Class III · Low risk
Clindamycin Phosphate Topical Solution USP
CGMP Deviations: an expired active ingredient was used in the manufacture of these recalled lots.
Class III · Low risk
Penicillin V Potassium Tablets
Presence of Foreign Tablet/Capsule; Amoxicillin 500 mg was found in bottles of Penicillin V potassium 500 mg
Class III · Low risk
Fluocinolone Acetonide Topical Solution USP 0.01% For Topical Use Only
Chemical Contamination
Class III · Low risk
A+D Diaper Rash Cream with Dimethicone 1% and Zinc Oxide 10%
Labeling: Incorrect/Undeclared Excipients: Firm is recalling A+D Diaper Rash Cream due to a labeling claim issue.