Class II · Moderate risk Terminated
Auryxia
Reason cGMP deviations: Lots recalled were not manufactured in conformance with the FDA-approved manufacturing process for Auryxia.
FDA Drug Recalls
14,801 recalls, newest first
Class II · Moderate risk Terminated
Shine & Clean Hand Sanitizer gel
Reason CGMP Deviations: Products manufactured at the same site were FDA testing found below the label claim for ethanol content and the presence of undeclared methanol.
Class I · High risk Terminated
Daptomycin for Injection
Reason Presence of Particulate Matter
Class II · Moderate risk Terminated
Metformin Hydrochloride Extended-Release Tablets USP 1000 mg
Reason CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
Class II · Moderate risk Terminated
Metformin Hydrochloride Extended-Release Tablets USP 500 mg
Reason CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
Class II · Moderate risk Terminated
Metformin Hydrochloride Extended-Release Tablets USP 1000 mg
Reason CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
Class II · Moderate risk Terminated
Metformin Hydrochloride Extended-release Tablets USP 500 mg
Reason CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
Class I · High risk Terminated
BD ChloraPrep Hi-Lite Orange 2% w/v chlorhexidine gluconate
Reason Non-sterility: Product is being recalled to climatic Zone IV regions of the world where at the labeled storage conditions of 30*C/75% Relative Humidity for more than 6 months, there is the potential for growth of Aspergillus penicillioides, a type of fungus, resulting in a breach of the package integrity.
Class I · High risk Terminated
ChloraPrep One-Step 2% w/v chlorhexidine gluconate
Reason Microbial Contamination of Non-Sterile Product: Product is being recalled to climatic Zone IV regions of the world where at the labeled storage conditions of 30*C/75% Relative Humidity for more than 6 months, there is the potential for growth of Aspergillus penicillioides, a type of fungus, resulting in a breach of the package integrity.
Class I · High risk Terminated
ChloraPrep With Tint 2% w/v chlorhexidine gluconate
Reason Microbial Contamination of Non-Sterile Products:Product is being recalled to climatic Zone IV regions of the world where at the labeled storage conditions of 30*C/75% Relative Humidity for more than 6 months, there is the potential for growth of Aspergillus penicillioides, a type of fungus, resulting in a breach of the package integrity.
Class I · High risk Terminated
BD ChloraPrep Clear
Reason Non-sterility: Product is being recalled to climatic Zone IV regions of the world where at the labeled storage conditions of 30*C/75% Relative Humidity for more than 6 months, there is the potential for growth of Aspergillus penicillioides, a type of fungus, resulting in a breach of the package integrity.
Class III · Low risk Terminated
Clonazepam Orally Disintegrating Tablets
Reason Cross contamination with other products - OOS discovered during routine stability testing for highest unknown impurity later identified as clozapine
Class III · Low risk Terminated
Skin Medica Acne System
Reason SUBPOTENT DRUG: Products failed assay results at the 12 and 24 month timepoints.
Class III · Low risk Terminated
Skin Medica Acne Treatment Lotion
Reason SUBPOTENT DRUG: Products failed assay results at the 12 and 24 month timepoints.
Class I · High risk Terminated
bio aaa Advance Hand Sanitizer Ethyl Alcohol 70%
Reason Chemical Contamination: Product contains methanol.
Class II · Moderate risk Terminated
bio aaa Advance Hand Sanitizer Ethyl Alcohol 70%
Reason CGMP Deviations
Class II · Moderate risk Terminated
Vancomycin HCL 1.5 mg Edge Pharma
Reason Labeling: Label Error on Declared Strength
Class II · Moderate risk Terminated
Yohimbine HCL 5.4mg Capsule
Reason Lack of Processing Controls (lack of assurance of conformity to specifications).
Class II · Moderate risk Terminated
Vardenafil 20 mg Troche
Reason Lack of Processing Controls (lack of assurance of conformity to specifications).
Class II · Moderate risk Terminated
Testosterone/Anastrozole Pellet 100/6 mg
Reason Lack of Processing Controls (lack of assurance of conformity to specifications).
Class II · Moderate risk Terminated
Tadalafil 7 mg Capsule
Reason Lack of Processing Controls (lack of assurance of conformity to specifications).
Class II · Moderate risk Terminated
Tadalafil 3 mg Capsule
Reason Lack of Processing Controls (lack of assurance of conformity to specifications).
Class II · Moderate risk Terminated
Tadalafil 26 mg Capsule
Reason Lack of Processing Controls (lack of assurance of conformity to specifications).
Class II · Moderate risk Terminated
Tadalafil 18 mg Capsule
Reason Lack of Processing Controls (lack of assurance of conformity to specifications).
Class II · Moderate risk Terminated
Tadalafil 12 mg Capsule
Reason Lack of Processing Controls (lack of assurance of conformity to specifications).