Class III โ€” Low Risk

Low risk โ€” use of or exposure to this product is not likely to cause adverse health consequences.

PLUVICTO 1 Recalled by Advanced Accelerator Applications USA, Inc. Due to Labeling: Incorrect or Missing Lot and/or Exp Date:...

Date: August 7, 2023
Company: Advanced Accelerator Applications USA, Inc.
Status: Terminated
Source: FDA (Drug)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Advanced Accelerator Applications USA, Inc. directly.

Affected Products

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

Quantity: 10

Why Was This Recalled?

Labeling: Incorrect or Missing Lot and/or Exp Date: vials were labeled with the incorrect lot number and expiration date

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Advanced Accelerator Applications USA, Inc.

Advanced Accelerator Applications USA, Inc. has 4 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report