Class II · Moderate risk
N-A-C
Mislabeling of SUS (N-A-C Sustain 600 mg 100 tab) with N-A-C N-Acetyl-L-Cysteine 500 mg, 100 cap.
FDA Drug Recalls
708 recalls · Class II, newest first
Class II · Moderate risk
Salicylic Acid Shampoo 3%
GMP Deviations
Class II · Moderate risk
DCL Clear Skin Anti-Blemish Hydrator
GMP Deviations
Class II · Moderate risk
DCL Alpha Beta Gel Toner
GMP Deviations
Class II · Moderate risk
Willa Pore Perfector
GMP Deviations
Class II · Moderate risk
Willa Clear Skin
GMP Deviations
Class II · Moderate risk
MD Complete Breakout Treatment
GMP Deviations
Class II · Moderate risk
(Malin+Goetz) spf 30 face moisturizer
GMP Deviations
Class II · Moderate risk
(Malin + Goetz) Salicylic Gel
GMP Deviations
Class II · Moderate risk
Class II · Moderate risk
DCL T Shampoo for Hair and Body
GMP Deviations
Class II · Moderate risk
DCL SA Scalp Therapy Shampoo
GMP Deviations
Class II · Moderate risk
DCL AHA Lightening Gel
GMP Deviations
Class II · Moderate risk
DCL B Prox10 Anti-Blemish Wash
GMP Deviations
Class II · Moderate risk
DCL Active Mattifying Cleanser
GMP Deviations
Class II · Moderate risk
Metformin Hydrochloride Extended-Release Tablets
CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level (per manufacturer)
Class II · Moderate risk
Metformin Hydrochloride Extended-Release Tablets USP 750 mg
CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level (per manufacturer)
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