FDAFDA · Food and drugs·Recall number D-1085-2023
PLUVICTO 1,000MBq/mL (27 mCi/mL), lutetium Lu 177 vipivotide tetraxetan injection, 9.2 mL Single-dose vial, Manufacturer: Advanced Accelerator Appllications USA, Inc., 57 E. Willow Street NJ 07041, Milburn, USA, NDC 69488-010-61
Published August 23, 2023 · Recall initiated: August 7, 2023
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Labeling: Incorrect or Missing Lot and/or Exp Date: vials were labeled with the incorrect lot number and expiration date
What to do
Voluntary: Firm initiated
Recall details
- Manufacturer
- Advanced Accelerator Applications USA, Inc.
- Distributor
- Distributed Nationwide in the USA
- Lot
- Lot # LPS230729B-16, Exp 8/3/2023 at 10:00am, LPS230804B-16, Exp 8/9/2023 at 10:00am.
- Risk classification
- Class III
- Area (FDA)
- drug
- Country
- United States
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