239 recalls · Class II, newest first
Reason Presence of Foreign Tablet/Capsule: A stray Rasagiline Mesylate 1 mg tablet was discovered in an unopened bottle of Ibuprofen and Famotidine.
Reason Presence of Foreign Tablets/Capsules
Reason Lack of Sterility Assurance
Reason CGMP Deviations: Firm reported possible microbial contamination in the purified water used in the manufacturing of the products. No contamination was…
Reason CGMP Deviations: Firm reported possible microbial contamination in the purified water used in the manufacturing of the products. No contamination was…
Reason CGMP Deviations: Firm reported possible microbial contamination in the purified water used in the manufacturing of the products. No contamination was…
Reason CGMP Deviations: Firm reported possible microbial contamination in the purified water used in the manufacturing of the products. No contamination was…
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 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: Stability data does not support expiry date.
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
Reason Failed Impurities/Degradation Specifications
Reason Labeling: Label Mix-Up-Indomethacin bottles may be labeled as Naproxen
Reason Labeling: Label Mix-Up-Indomethacin bottles may be labeled as Naproxen
Reason Failed Tablets/Capsules specifications; missing/broken/extra tablets within the capsules
Reason Failed Impurities/Degradation Specifications-Out of specification (OOS) results for the excipient Amadori Glucose adduct of Paroxetine
Reason Failed Impurities/Degradation Specifications-Out of specification (OOS) results for the excipient Amadori Glucose adduct of Paroxetine