Class III · Low risk
Olanzapine Tablets
Failed Impurities/Degradation Specifications: out of specification results for the related substances test parameter (impurities).
Class III drug recalls - low risk
Class III means the product is unlikely to cause harm but violates FDA labeling or manufacturing rules. These are the recalls you rarely hear about; pharmacies usually just swap the affected lot.
1,716 recalls, newest first.
Class III · Low risk
Olanzapine Tablets
Failed Impurities/Degradation Specifications: out of specification results for the related substances test parameter (impurities).
Class III · Low risk
Olanzapine Tablets
Failed Impurities/Degradation Specifications: out of specification results for the related substances test parameter (impurities).
Class III · Low risk
Pilocarpine Hydrochloride Ophthalmic Solution 4%
Failed Impurities/Degradation Specifications.
Class III · Low risk
Isopto Carpine
Failed Impurities/Degradation Specifications.
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Labeling: Incorrect or Missing Package Insert: product lots packaged with an out-of-date insert.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.