Why it was recalled
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
Lot numbers, UPCs & expiration codes
Lot # LPS230729B-16, Exp 8/3/2023 at 10:00am, LPS230804B-16, Exp 8/9/2023 at 10:00am.
Where it was sold
Distributed Nationwide in the USA
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-1085-2023
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Aug 7, 2023
- FDA report date
- Aug 23, 2023
- Quantity
- 10
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Advanced Accelerator Applications USA, Inc.
Original FDA data
Every field from FDA enforcement report D-1085-2023, exactly as published.
Show all FDA fields
- City
- Millburn
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 92845
- Address
- 57 E Willow St
- Code information
- Lot # LPS230729B-16, Exp 8/3/2023 at 10:00am, LPS230804B-16, Exp 8/9/2023 at 10:00am.
- Postal code
- 07041-1416
- Report date
- Aug 23, 2023
- Product type
- Drugs
- Recall number
- D-1085-2023
- Classification
- Class III
- Recalling firm
- Advanced Accelerator Applications USA, Inc.
- Product quantity
- 10
- Termination date
- Mar 12, 2024
- Reason for recall
- Labeling: Incorrect or Missing Lot and/or Exp Date: vials were labeled with the incorrect lot number and expiration date
- Voluntary / mandated
- Voluntary: Firm initiated
- 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
- Recall initiation date
- Aug 7, 2023
- Center classification date
- Aug 15, 2023