Class II · Moderate risk Ongoing
Nivagen
Reason cGMP deviations
FDA Drug Recalls
2,661 recalls, newest first
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.
Class II · Moderate risk Ongoing
Lanthanum Carbonate chewable tablets
Reason Failed stability specifications: Out of specification for hardness test
Class II · Moderate risk Ongoing
Lanthanum Carbonate chewable tablets
Reason Failed stability specifications: Out of specification for hardness test
Class II · Moderate risk Ongoing
Bromocriptine Mesylate Capsules
Reason Failed Impurities/Degradation Specifications: Out of Specification (OOS) result reported for 2- Bromoergine impurity of Bromocriptine Mesylate Capsules.