Pluvicto 1 recall: Labeling Error
PLUVICTO 1,000MBq/mL (27 mCi/mL), lutetium Lu 177 vipivotide tetraxetan injection, 9.2 mL Single-dose vial, Manufacturer: Advanced Accelerator…
Why was Pluvicto 1 recalled?
Labeling: Incorrect or Missing Lot and/or Exp Date: vials were labeled with the incorrect lot number and expiration date
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot # LPS230729B-16, Exp 8/3/2023 at 10:00am, LPS230804B-16, Exp 8/9/2023 at 10:00am.
- Product
- PLUVICTO 1,000MBq/mL (27 mCi/mL), lutetium Lu 177 vipivotide tetraxetan injection, 9.2 mL Single-dose vial, Manufacturer: Advanced Accelerator…
- Recalling firm
- Advanced Accelerator Applications USA, Inc.
- Quantity
- 10
- Distribution
- Distributed Nationwide in the USA
- Recall date
- August 23, 2023
- Classification
- Class III
- Status
- Terminated
- Agency
- FDA (drug)