Class II · Moderate risk Ongoing
Globe Zinc Oxide Ointment USP Zinc Oxide 20% Skin Protectant
Reason cGMP deviations
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Class II · Moderate risk Ongoing
Globe Clotrimazole Cream USP
Reason cGMP deviations
Class II · Moderate risk Ongoing
Globe Clotrimazole Cream
Reason cGMP deviations
Class II · Moderate risk Ongoing
Nivagen
Reason cGMP deviations
Class II · Moderate risk Ongoing
Nivagen
Reason cGMP deviations
Class II · Moderate risk Ongoing
Dynashield
Reason cGMP deviations
Class II · Moderate risk Ongoing
Nivagen Pharmaceuticals
Reason cGMP deviations
Class II · Moderate risk Ongoing
WeCare
Reason cGMP deviations
Class II · Moderate risk Ongoing
Dynagel
Reason cGMP deviations
Class II · Moderate risk Ongoing
Wecare Enema
Reason cGMP deviations
Class II · Moderate risk Ongoing
Dynashield Skin Protectant
Reason cGMP deviations
Class II · Moderate risk Ongoing
Lanashield Skin Barrier
Reason cGMP deviations
Class II · Moderate risk Ongoing
Phytonadione Injectable Emulsion
Reason Failed Stability Specifications: Observed OOS results: eg results for colour index
Class I · High risk Ongoing
POTASSIUM CHLORIDE Inj.
Reason 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 Ongoing
POTASSIUM CHLORIDE Inj.
Reason 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 Ongoing
Agebox iKids-Growth
Reason Marketed Without an Approved NDA/ANDA: presence of undeclared ibutamoren
Class II · Moderate risk Ongoing
Agebox iKids-Growth
Reason Marketed Without an Approved NDA/ANDA: presence of undeclared ibutamoren
Class II · Moderate risk Ongoing
Lisdexamfetamine Dimesylate Capsules
Reason 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 Ongoing
Lisdexamfetamine Dimesylate Capsules
Reason 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 Ongoing
Lisdexamfetamine Dimesylate Capsules
Reason 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 Ongoing
Lisdexamfetamine Dimesylate Capsules
Reason 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 Ongoing
Lisdexamfetamine Dimesylate Capsules
Reason 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 Ongoing
Lisdexamfetamine Dimesylate Capsules
Reason 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 Ongoing
Lisdexamfetamine Dimesylate Capsules
Reason 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 Ongoing
0.9% SODIUM CHLORIDE Injection
Reason Lack of Assurance of Sterility: Potential for flexible container leaks.