Advanced Accelerator Applications USA, Inc.: Drug Recall
Recall #D-1085-2023 · 08/07/2023
Class III: Low Risk
Recall Details
- Recall Number
- D-1085-2023
- Classification
- Class III
- Product Type
- Drug
- Recalling Firm
- Advanced Accelerator Applications USA, Inc.
- Status
- Terminated
- Date Initiated
- 08/07/2023
- Location
- Millburn, NJ, United States
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 10
Reason for Recall
Labeling: Incorrect or Missing Lot and/or Exp Date: vials were labeled with the incorrect lot number and expiration date
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
Distribution Pattern
Distributed Nationwide in the USA
Other Recalls by Advanced Accelerator Applications USA, Inc.
- Class II: Risk 09/23/2024
- Class III: Low Risk 03/18/2022
View all recalls by Advanced Accelerator Applications USA, Inc. →
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.