Advanced Accelerator Applications USA, Inc. 2024-10-09 Health serious FDA
Health · FDA · Recall #FDA-D-0007-2025
Pluvicto, 1000 MBq/mL (27 mCi/mL), lutetium, LU 177, vipivotide tetraxetan injection,… Recall
Issued October 9, 2024 · Advanced Accelerator Applications USA, Inc.
In October 2024, Advanced Accelerator Applications USA, Inc. recalled the Pluvicto, 1000 MBq/mL (27 mCi/mL), lutetium, LU 177, vipivotide tetraxetan injection,…, a serious health recall reported by the FDA.
Compiled by Maya Ellison, RecallCheckr
What this means for you
CGMP deviations
What you should do
- 1 Stop using Pluvicto, 1000 MBq/mL (27 mCi/mL), lutetium, LU 177, vipivotide tetraxetan injection,… right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact Advanced Accelerator Applications USA, Inc. to arrange your voluntary. See the official notice below for contact details.
- 4 Keep the product until your remedy is fully processed. You may need it.
Official remedy (Voluntary):
Recall details
- Brand
- Advanced Accelerator Applications USA, Inc.
- Category
- Health
- Recall date
- October 9, 2024
- Units affected
- Not reported
- Sold at
- FL, MA, NJ, NY, PA, and VA
- Recall number
- FDA-D-0007-2025
- Made in
- United States
- Issuing agency
- FDA
In context
- Advanced Accelerator Applications USA, Inc. has 2 recalls in our database.
- We're tracking 3,576 Health recalls in our database.
- This is the 737th Health recall we've logged in 2024.