1,122 recalls, newest first
Reason MICROBIAL CONTAMINATION OF NON-STERILE PRODUCTS - Presence of Acetobacter nitrogenifigens bacteria.
Reason MICROBIAL CONTAMINATION OF NON-STERILE PRODUCTS - Presence of Acetobacter nitrogenifigens bacteria.
Reason MICROBIAL CONTAMINATION OF NON-STERILE PRODUCTS - Presence of Acetobacter nitrogenifigens bacteria.
Reason CGMP Deviations: N-Nitroso Desloratadine impurity result exceeded the acceptable intake limit.
Reason Presence of Foreign Tablets/Capsules: One 0.5 mg Tacrolimus capsule found in a bottle of 1 mg Tacrolimus capsules.
Reason CGMP Deviations: Stability data does not support expiry date.
Reason Failed Release Testing: Coarse Particle Mass for umeclidinium Out of Specification
Reason CGMP Deviations: Inadequate line clearance which may result in a potential comingling of product.
Reason Labeling: Label Error on Declared Strength: Assay value on the label is incorrect.
Reason Labeling: Label Error on Declared Strength: Assay value on the label is incorrect.
Reason Labeling: Label Error on Declared Strength: Assay value on the label is incorrect.
Reason Labeling: Label Error on Declared Strength: Assay value on the label is incorrect.
Reason Failed Impurities/Degradation Specifications: Out of specification Impurity C (4,5-desisopropylidene topiramate) result observed during routine…
Reason Failed Impurities/Degradation Specifications
Reason Marketed without an approved NDA/ANDA: Magnum XXL found to contain undeclared active pharmaceutical ingredient (API) - Sildenafil.
Reason STAQ Pharma Inc. received consumer complaints related to leaking bags and other potential bag concerns. Upon investigation, they determine the source…
Reason Presence of Particulate Matter.
Reason Presence of Particulate Matter.
Reason Chemical Contamination; presence of benzene.
Reason Failed Dissolution Specifications
Reason Crystallization: bottles of Sandimmune Oral Solution were determined to contain crystals
Reason Lack of assurance of sterility.
Reason Failed Dissolution Specifications
Reason Failed Dissolution Specifications
Reason Defective Container: powder may leak out of the pouch