D-1085-2023 Class III Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- August 23, 2023
- Initiation Date
- August 7, 2023
- Termination Date
- March 12, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 10
Product Description
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
Reason for Recall
Labeling: Incorrect or Missing Lot and/or Exp Date: vials were labeled with the incorrect lot number and expiration date
Distribution Pattern
Distributed Nationwide in the USA
Code Information
Lot # LPS230729B-16, Exp 8/3/2023 at 10:00am, LPS230804B-16, Exp 8/9/2023 at 10:00am.