778 recalls, newest first
Reason CGMP Deviations; particulates identified during visual inspection
Reason CGMP Deviations; particulates identified during visual inspection
Reason Subpotent Drug
Reason Subpotent Drug
Reason Subpotent Drug
Reason Subpotent Drug
Reason Failed Dissolution Specifications.
Reason Sub-Potent Drug: Subpotent assay results during stability testing.
Reason Sub-Potent Drug: Subpotent assay results during stability testing.
Reason CGMP Deviations: detection of N-nitroso-dimethyl-rizatriptan impurity, above the FDA recommended acceptable intake limit.
Reason CGMP Deviations: detection of N-nitroso-dimethyl-rizatriptan impurity, above the FDA recommended acceptable intake limit.
Reason Subpotent Drug- isopropyl alcohol levels fall below the labeled concentration.
Reason Subpotent Drug- isopropyl alcohol levels fall below the labeled concentration.
Reason Subpotent Drug- isopropyl alcohol levels fall below the labeled concentration.
Reason Subpotent Drug- isopropyl alcohol levels fall below the labeled concentration.
Reason Subpotent Drug- isopropyl alcohol levels fall below the labeled concentration.
Reason Subpotent Drug- isopropyl alcohol levels fall below the labeled concentration.
Reason Defective Container: spike of the cap becomes lodged in the nozzle of the product bottle.
Reason Labeling: Incorrect or Missing Lot and/or Exp Date: released with wrong expiry date as Feb.2027 instead of Jan.2027
Reason Lack of Processing Controls; prescriptions were compounded in an ISO-5 area where it was identified that a daily cleaning step was not sufficiently…
Reason Lack of Assurance of Sterility: A market complaint was received for leakage and empty ampoule.
Reason Presence of foreign tablets/capsules: presence of foreign Divalproex Sodium Extended-Release 250mg tablet in a bottle of omeprazole capsules.
Reason CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
Reason Labeling: Label Mix-Up; Some vials of Cefazolin for Injection, USP 1 gram were incorrectly labeled as penicillin G potassium for Injection, USP, 20…
Reason Labeling: Label Mix-Up; cartons of Cefazolin for Injection, USP 1 gram were found to contain vials labeled as penicillin G potassium for Injection…