In a lengthy investigative piece, the Chicago Tribune reports on apparent FDA failures to identify two batches of syringes “from a contaminated lot made in a factory owned by a Lake Zurich (Il) businessman.” Two batches from the plant “have since been linked to four deaths and 162 illnesses nationwide, including 22 in Illinois.” Documents show that the U.S. Food and Drug Administration “missed several chances to stop the tainted syringes from being used by patients. Three months before the prefilled syringes were shipped in October 2007, an FDA inspector visited the plant in North Carolina where they were made” and investigated “reports of red, brown and black particles in syringes and reported that managers had a plan to deal with rust.”
Hamburg responds to AM2PAT syringe story. The Chicago Tribune reports, “The Food and Drug Administration’s newly sworn commissioner promised a more aggressive approach to product safety in response to a ProPublica and Chicago Tribune report about the agency’s oversight of a North Carolina plant that produced syringes contaminated with bacteria.”From the American Association for Justice news release.
From the American Association for Justice news release.