FDARecalled Aug 23, 2023 · #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...
Hazard
Class III — low health risk
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Labeling: Incorrect or Missing Lot and/or Exp Date: vials were labeled with the incorrect lot number and expiration date Classification: Class III Distribution: Distributed Nationwide in the USA
Product details
- Product
- 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
- Type
- Drugs
- Manufacturer
- Advanced Accelerator Applications USA, Inc.
- Model numbers
- LPS230729B-16
- UPCs
- —