Recalls / Class III
Class IIID-1085-2023
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
- Affected lot / code info
- Lot # LPS230729B-16, Exp 8/3/2023 at 10:00am, LPS230804B-16, Exp 8/9/2023 at 10:00am.
Why it was recalled
Labeling: Incorrect or Missing Lot and/or Exp Date: vials were labeled with the incorrect lot number and expiration date
Recalling firm
- Firm
- Advanced Accelerator Applications USA, Inc.
- Type
- Voluntary: Firm initiated
- Address
- 57 E Willow St, Millburn, New Jersey 07041-1416
Distribution
- Quantity
- 10
- Distribution pattern
- Distributed Nationwide in the USA
Timeline
- Recall initiated
- 2023-08-07
- FDA classified
- 2023-08-15
- Posted by FDA
- 2023-08-23
- Terminated
- 2024-03-12
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1085-2023. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.