GMP deviation; Sr-82 levels exceeded alert limit specification
GMP deviation; Sr-82 levels exceeded alert limit specification
We break every recall down into plain English — this one’s still on our list. Until our write-up is ready, the official FDA hazard and remedy below have the full, accurate details.
We’ve drafted a message you can send Bracco Diagnostics Inc. to request your refund or repair — edit it as you like.
Subject: Recall D-1684-2012 — Bracco Diagnostics Inc. Bracco Diagnostics Inc recalls CARDIOGEN-82 (Rubidium Rb 82 Generator), 140 Hello, I own a Bracco Diagnostics Inc recalls CARDIOGEN-82 (Rubidium Rb 82 Generator), 140 millicurie, Rx Only, For Elution of sterile nonpyrogenic Rubidium Chloride that is covered by recall D-1684-2012 from Bracco Diagnostics Inc.. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
