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Undeclared allergens (Peanut) due to mispackaging
Subpotent Drug- isopropyl alcohol levels fall below the labeled concentration.
Defective Container: spike of the cap becomes lodged in the nozzle of the product bottle.
Lack of pasteurization and sanitation records
Labeling: Incorrect or Missing Lot and/or Exp Date: released with wrong expiry date as Feb.2027 instead of Jan.2027
Lack of Processing Controls; prescriptions were compounded in an ISO-5 area where it was identified that a daily cleaning step was not sufficiently documented.
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
Lack of Assurance of Sterility: A market complaint was received for leakage and empty ampoule.
Presence of foreign tablets/capsules: presence of foreign Divalproex Sodium Extended-Release 250mg tablet in a bottle of omeprazole capsules.
Potential Listeria Monocytogenes Contamination