Class III · Low risk Terminated
Ciclopirox Olamine Cream USP
Reason Labeling: Incorrect or Missing Package Insert: product lots packaged with an out-of-date insert.
FDA Drug Recalls
1,709 recalls · Class III, newest first
Class III · Low risk Terminated
Fluocinonide Cream UPS
Reason 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 Terminated
Lumigan
Reason Failed Impurities/Degradation Specifications
Class III · Low risk Terminated
Fluphenazine Decanoate Injection
Reason Subpotent Drug
Class III · Low risk Terminated
Adalat CC
Reason Cross Contamination with another product:residual powder found in inlet air duct identified as sorafenib
Class III · Low risk Terminated
Adalat CC
Reason Cross Contamination with another product:residual powder found in inlet air duct identified as sorafenib
Class III · Low risk Terminated
Adalat CC
Reason Cross Contamination with another product:residual powder found in inlet air duct identified as sorafenib
Class III · Low risk Terminated
Adalat CC
Reason Cross Contamination with another product:residual powder found in inlet air duct identified as sorafenib
Class III · Low risk Terminated
Nifedipine Extended-Release Tablets
Reason Cross Contamination with another product:residual powder found in inlet air duct identified as sorafenib
Class III · Low risk Terminated
Nifedipine Extended-Release Tablets
Reason Cross Contamination with another product:residual powder found in inlet air duct identified as sorafenib
Class III · Low risk Terminated
Adalat CC
Reason Cross Contamination with another product:residual powder found in inlet air duct identified as sorafenib
Class III · Low risk Terminated
Adalat CC
Reason Cross Contamination with another product:residual powder found in inlet air duct identified as sorafenib
Class III · Low risk Terminated
Nifedipine Extended-Release Tablets
Reason Cross Contamination with another product:residual powder found in inlet air duct identified as sorafenib
Class III · Low risk Terminated
Quillivant XR
Reason Failed Dissolution Specifications: Dissolution at 8 hour was out of specification at 12 month at 25 degree Celsius.
Class III · Low risk Terminated
Quillivant XR
Reason Failed Dissolution Specifications: Dissolution at 8 hour was out of specification at 12 month at 25 degree Celsius.
Class III · Low risk Terminated
Quillivant XR
Reason Failed Dissolution Specifications: Dissolution at 8 hour was out of specification at 12 month at 25 degree Celsius.
Class III · Low risk Terminated
Indian God Lotion Spray Bottle
Reason 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 Terminated
RIVASTIGMINE Tartrate Capsules
Reason 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 Terminated
Clindamycin Phosphate Topical Solution USP
Reason CGMP Deviations: an expired active ingredient was used in the manufacture of these recalled lots.
Class III · Low risk Terminated
Penicillin V Potassium Tablets
Reason Presence of Foreign Tablet/Capsule; Amoxicillin 500 mg was found in bottles of Penicillin V potassium 500 mg
Class III · Low risk Terminated
Fluocinolone Acetonide Topical Solution USP 0.01% For Topical Use Only
Reason Chemical Contamination
Class III · Low risk Terminated
A+D Diaper Rash Cream with Dimethicone 1% and Zinc Oxide 10%
Reason Labeling: Incorrect/Undeclared Excipients: Firm is recalling A+D Diaper Rash Cream due to a labeling claim issue.
Class III · Low risk Terminated
Potassium PHOSphate added to 0.9% Sodium Chloride
Reason Labeling: Not Elsewhere Classified: Incorrect volume printed on the product label.
Class III · Low risk Terminated
Potassium PHOSphate added to 0.9% Sodium Chloride
Reason Labeling: Not Elsewhere Classified: Incorrect volume printed on the product label.
Class III · Low risk Terminated
Potassium PHOSphate added to 0.9% Sodium Chloride
Reason Labeling: Not Elsewhere Classified: Incorrect volume printed on the product label.