37 recalls, newest first
Reason CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
Reason Subpotent Drug
Reason Failed Impurities/Degradation Specifications: Out-of-specification results obtained for related impurities and slightly lower than the established…
Reason CGMP Deviations: sterile water not used for production
Reason CGMP Deviations: sterile water not used for production
Reason Presence of Foreign Tablets: Potential presence of Fludrocortisone Acetate Tablet USP 0.1 mg within the Methotrexate 2.5 mg 100-count Bottle.
Reason Cross contamination with other products
Reason Cross contamination with other products
Reason CGMP Deviations and Presence of Particulate Matter: Glass
Reason Product Mix Up. A bottle of Phenazopyridine HCl tablets USP 100 mg contained Phenobarbital tablets 16.2 mg.
Reason Failed Impurities/Degradation Specifications
Reason Failed Impurities/Degradation Specifications
Reason Labeling: Wrong Barcode
Reason Labeling: Label mix-up - ephedrine syringes mislabeled as phenylephrine.
Reason Failed Tablet/Capsule Specifications: There is a potential for the imprint, M 122, to be missing on some tablets.
Reason Presence of Foreign Substance; Broken metal piece found embedded in tablet.
Reason cGMP Deviations
Reason Failed dissolution specifications: out-of-specification bempedoic acid dissolution at the 0-month timepoint.
Reason Failed Dissolution Specifications
Reason CGMP Deviations
Reason Failed Stability Specifications
Reason Failed Stability Specifications
Reason Subpotent Drug: Out of specification for assay
Reason Chemical Contamination; presence of benzene.
Reason CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.