Class II · Moderate risk
Cinacalcet Hydrochloride Tablets
CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits.
FDA Drug Recalls
2,357 recalls · Class II, newest first
Class II · Moderate risk
Cinacalcet Hydrochloride Tablets
CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits.
Class II · Moderate risk
Ganirelix Acetate Injection
Failed impurities/degradation specifications: out of specification results for Ganirelix acetate acrylic acid adduct impurity.
Class II · Moderate risk
Walgreens Saline Nasal Spray WITH XYLITOL
Microbial contamination of a non-sterile product - microorganism found to be pseudomonas lactis
Class II · Moderate risk
Sertraline Hydrochloride Tablets USP
Defective container - seal not adhering to bottles
Class II · Moderate risk
OraVerse
Defective container: cracked/broken cartridges
Class II · Moderate risk
Cook-Walte
Defective container: cracked/broken cartridges
Class II · Moderate risk
Benco dental Graham CHEMICAL CO.
Defective container: cracked/broken cartridges
Class II · Moderate risk
darby dental supply
Defective container: cracked/broken cartridges
Class II · Moderate risk
3% Polocaine DENTAL
Defective container: cracked/broken cartridges
Class II · Moderate risk
Lidocaine HCI 2% and Epinephrine 1:100
Defective container: cracked/broken cartridges
Class II · Moderate risk
2% Xylocaine DENTAL with Epinephrine 1:100
Defective container: cracked/broken cartridges
Class II · Moderate risk
Wecare Calasoothe
cGMP deviations
Class II · Moderate risk
Globe Zinc Oxide Ointment USP Zinc Oxide 20% Skin Protectant
cGMP deviations
Class II · Moderate risk
Globe Clotrimazole Cream USP
cGMP deviations
Class II · Moderate risk
Globe Clotrimazole Cream
cGMP deviations
Class II · Moderate risk
Nivagen
cGMP deviations
Class II · Moderate risk
Nivagen
cGMP deviations
Class II · Moderate risk
Dynashield
cGMP deviations
Class II · Moderate risk
Nivagen Pharmaceuticals
cGMP deviations
Class II · Moderate risk
WeCare
cGMP deviations
Class II · Moderate risk
Dynagel
cGMP deviations
Class II · Moderate risk
Wecare Enema
cGMP deviations
Class II · Moderate risk
Dynashield Skin Protectant
cGMP deviations
Class II · Moderate risk
Lanashield Skin Barrier
cGMP deviations