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Amgen recently announced three incidents of product tampering. In a letter to health care providers, Amgen states that flip caps from the tops of eight vials from different lots of Epogen (Epoetin alfa) and Neupogen (filgrastim) were detached. The contents of the vials were then removed and replaced with varying amounts of an aqueous solution, then resealed.
None of these vials was used, either because crusty, white material was detected below the caps or because particulate matter was seen in solution. The lots involved were Epogen lots P000839, P000841, and Neupogen 300 mcg lots P000928 and P000698.
Amgen’s plea to health care providers about this situation is good advice for pharmacists to heed for all injectables: "If you see any evidence of tampering of vials, e.g., vials that appear to have been opened, have white crusty deposits around the stopper, appear to contain discolored or cloudy fluid, particulate matter, volumes less or greater than expected, or if the labels appear worn, DO NOT USE the vials and call the manufacturer."
Amgen’s letter to health care providers can be viewed at www.fda.gov/MedWatch/safety/2001/safety01.htm#epogen.