Drug 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
D-1085-2023
Product summary
- Event
- Event 92845
- Status
- Terminated
- Classification
- Class III
- Quantity
- 10
- Official record key
drug-enforcement:D-1085-2023
Official wording
Reason: Labeling: Incorrect or Missing Lot and/or Exp Date: vials were labeled with the incorrect lot number and expiration date
Code information: Lot # LPS230729B-16, Exp 8/3/2023 at 10:00am, LPS230804B-16, Exp 8/9/2023 at 10:00am.
Distribution pattern: Distributed Nationwide in the USA
Derived failure modes
-
Labeling or packaging
Labeling: Incorrect or Missing