676 recalls · Class II, newest first
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 Failed Impurities/Degradation Specifications: an out of specification result observed in degradation product test (any unspecified degradation…
Reason Failed Dissolution Specifications: Product failed to meet dissolution acceptance criteria in the stability studies at the 6th month (25¿C/60% RH)…
Reason Product Mix Up: This product is being recalled because of a complaint received that a sealed bottle of lisinopril and hydrochlorothiazide tablets…
Reason Subpotent Drug: Assay below the approved specification
Reason Subpotent Drug: Assay below the approved specification
Reason Subpotent Drug: Assay below the approved specification
Reason Subpotent Drug: Assay below the approved specification
Reason Subpotent Drug: Assay below the approved specification
Reason Subpotent Drug: Assay below the approved specification
Reason Subpotent Drug: Assay below the approved specification
Reason Defective container; blister packaging inadequately sealed.