Class II · Moderate risk
DCL B Prox10 Anti-Blemish Wash
GMP Deviations
FDA Drug Recalls
11,818 recalls · Class II, newest first
Class II · Moderate risk
DCL Active Mattifying Cleanser
GMP Deviations
Class II · Moderate risk
Bupivacaine Hydrochloride in 8.25% Dextrose Injection
Presence of particulate matter in solution - black and transparent particles
Class II · Moderate risk
metformin HCL ER 750 mg Rx only Pkg By: PD-Rx Pharmaceuticals Incorporated Oklahoma City
CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level (per manufacturer)
Class II · Moderate risk
metformin HCL ER 500 mg
CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level (per manufacturer)
Class II · Moderate risk
Catapres (clonidine hydrochloride, USP)
An extraneous peak was observed for dissolution testing.
Class II · Moderate risk
Catapres (clonidine hydrochloride, USP)
An extraneous peak was observed for dissolution testing.
Class II · Moderate risk
Catapres (clonidine hydrochloride, USP)
An extraneous peak was observed for dissolution testing.
Class II · Moderate risk
Time-Cap Labs
CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
Class II · Moderate risk
Time-Cap Labs
CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
Class II · Moderate risk
Chlorhexidine Gluconate 20% 0012 Medichem
Discoloration.
Class II · Moderate risk
RIOMET ER (metformin hydrochloride for extended-release oral suspension)
CGMP Deviations: Detection of N-nitrosodimethylamine (NDMA) impurity in finished drug product.
Class II · Moderate risk
Nature-Throid 1 GR
CGMP deviations; repackaged product was recalled by the manufacturer because it was manufactured under the same conditions as products found to be sub-potent.
Class II · Moderate risk
Albuterol Sulfate Inhalation Aerosol
Defective Delivery System: Sustained trend of failure to dispense complaints.
Class II · Moderate risk
Phentermine
cMGP Deviations: Drug products repackaged into pouches without supporting stability studies.
Class II · Moderate risk
Diethylpropion
cMGP Deviations: Drug products repackaged into pouches without supporting stability studies.
Class II · Moderate risk
Diethylpropion
cMGP Deviations: Drug products repackaged into pouches without supporting stability studies.
Class II · Moderate risk
Buprenorphine Transdermal System 5 mcg/hour
Failed Stability Specifications: Below specification result for buprenorphine release rate.
Class II · Moderate risk
Eye Itch Relief
CGMP Deviations
Class II · Moderate risk
bio aaa Alcohol en Gel Antibacterial
CGMP Deviations: Product manufactured in a facility where methanol was found in other distributed lots of product.
Class II · Moderate risk
pH-D Feminine Health Boric Acid Vaginal Suppositories
Marketed without an Approved NDA/ANDA.
Class II · Moderate risk
Nature-Throid
CGMP Deviations
Class II · Moderate risk
Nature-Throid
CGMP Deviations
Class II · Moderate risk
Nature-Throid
CGMP Deviations
Class II · Moderate risk
Nature-Throid
CGMP Deviations