17,898 recalls, newest first
Reason Failed impurities/degradation specifications and Sub-potent Drug: Out-of-specification results were obtained during routine stability testing for…
Reason Out of Specification for Dissolution
Reason cGMP Deviations: Product intended for quarantine was inadvertently distributed.
Reason Labeling: Missing Label: The finished product potentially missing the labeling with the drug facts panel, bar code and directions for use.
Reason Failed Tablet/Capsule Specifications: Missing tab ID on either side of the tablet
Reason CGMP Deviations: presence of Nitrosamine Drug Substances Related Impurity (NDSRI), N-Nitroso-Duloxetine above the FDA recommended acceptable intake…
Reason Failed Stability Specifications - 12-month stability test result for one of the known peptides is below the specification limit
Reason Failed stability specifications: during routine stability monitoring quality concerns were identified. Physical separation for ingredients was…
Reason Superpotent; sodium benzoate preservative
Reason Presence of Foreign Tablets/Capsules
Reason Presence of Foreign Tablets/Capsules: A Paracetamol 500 mg tablet was found in a 1000-count bottle of Metformin HCL ER Tablets USP, 500 mg.
Reason CGMP Deviations; Presence of N-nitroso-duloxetine impurity above recommended interim limit.
Reason CGMP Deviations; Presence of N-nitroso-duloxetine impurity above recommended interim limit.
Reason CGMP Deviations; Presence of N-nitroso-duloxetine impurity above recommended interim limit.
Reason Presence of Particulate Matter: A market complaint was received of a glass piece in the vial.
Reason Failed Tablet/Capsule Specifications: Bottles shipped to the USA may contain empty capsules
Reason Failed Tablet/Capsule Specifications: Bottles shipped to the USA may contain empty capsules
Reason CGMP Deviations; product intended for quarantine was inadvertently distributed
Reason Failed Impurities/Degradation Specifications: Out of specification results observed for the impurity compound B during stability testing.
Reason Failed Impurities/Degradation Specifications: Out of specification results observed for the impurity compound B during stability testing.
Reason Labeling: Not Elsewhere Classified: misleading label similar in appearance to the FDA-approved drug product Adrenalin¿ (epinephrine injection, USP)
Reason Failed Impurities/Degradation Specifications: Out of specifications result observed in the drug substance for impurity test during 3-month long term…
Reason Failed Tablet/Capsule Specifications: Illegible product identification for the unit dose configuration only.
Reason Lack of Assurance of Sterility: The tamper-evident seal on several of the syringes are not attached upon receipt of shipment.
Reason Lack of Assurance of Sterility: The tamper-evident seal on several of the syringes are not attached upon receipt of shipment.