Class II · Moderate risk
Benco dental Graham CHEMICAL CO.
Defective container: cracked/broken cartridges
FDA Drug Recalls
18,003 recalls, newest first
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
Class II · Moderate risk
Phytonadione Injectable Emulsion
Failed Stability Specifications: Observed OOS results: eg results for colour index
Class I · High risk
POTASSIUM CHLORIDE Inj.
Labeling: Label Error on Declared Strength-The overwrap label may incorrectly identify the product as POTASSIUM CHLORIDE Inj. 10 mEq instead of POTASSIUM CHLORIDE Inj. 20 mEq
Class I · High risk
POTASSIUM CHLORIDE Inj.
Labeling: Label Error on Declared Strength-The overwrap label may incorrectly identify the product as POTASSIUM CHLORIDE Inj. 10 mEq instead of POTASSIUM CHLORIDE Inj. 20 mEq
Class II · Moderate risk
Agebox iKids-Growth
Marketed Without an Approved NDA/ANDA: presence of undeclared ibutamoren
Class II · Moderate risk
Agebox iKids-Growth
Marketed Without an Approved NDA/ANDA: presence of undeclared ibutamoren
Class II · Moderate risk
Lisdexamfetamine Dimesylate Capsules
Failed Dissolution Specifications: An out of specification results observed in dissolution test during analysis at 12-month long term stability station (25¿C, 60%RH) for Lisdexamfetamine dimesylate capsules.
Class II · Moderate risk
Lisdexamfetamine Dimesylate Capsules
Failed Dissolution Specifications: An out of specification results observed in dissolution test during analysis at 12-month long term stability station (25¿C, 60%RH) for Lisdexamfetamine dimesylate capsules.