Advanced Accelerator Applications USA, Inc. recalls Pluvicto, 1000 MBq/mL (27 mCi/mL), lutetium, LU 177, vipivotide tetraxetan injection, Single-dose vial, Sterile,…
CGMP deviations
Read the official notice →- Date
- 2024-10-09
- Country
- United States
- Brand
- Advanced Accelerator Applications
- Product
- Pluvicto, 1000 MBq/mL (27 mCi/mL), lutetium, LU 177, vipivotide tetraxetan injection, Single-dose vial, Sterile, Manufacturer Advanced…
- Classification
- Class II
- Units
- FL, MA, NJ, NY, PA, and VA
- Category
- Drugs & medical
- Source
- FDA · Drug
Copied automatically from the US Food and Drug Administration. Details may be shortened or out of date; the official notice is the authoritative source. Disclaimer
What to do
- Check the product name, strength and lot number against the official notice.
- Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
- Ask the pharmacy or supplier about a replacement or refund.
General guidance from Recall Atlas. The official notice from the US Food and Drug Administration has the exact models, batch codes and remedy, and it takes priority.
More Advanced Accelerator Applications recalls
- 2023-08-23
USAdvanced Accelerator Applications USA, Inc. recalls PLUVICTO 1,000MBq/mL (27 mCi/mL), lutetium Lu 177 vipivotide tetraxetan injection, 9.2 mL Single-dose vial,…
Labeling: Incorrect or Missing Lot and/or Exp Date: vials were labeled with the incorrect lot number and expiration date
FDA · DrugAdvanced Accelerator Applications USA, Inc.Distributed Nationwide in the USAOfficial notice →- 2022-04-13
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Subpotent Drug: low out-of-specification results for Vial 1 assay obtained during stability studies.
FDA · DrugAdvanced Accelerator Applications USA, Inc.Nationwide in the USA and Puerto RicoOfficial notice →
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