Reported Aug 23, 2023 · Terminated
PLUVICTO 1,000MBq/mL (27 mCi/mL), lutetium Lu 177 vipivotide tetraxetan injection, 9.2 mL Single-dose vial,…
Advanced Accelerator Applications USA, Inc.
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Advanced Accelerator Applications USA, Inc. · 57 E Willow St · Millburn, NJ · 07041-1416
Is this the product you have?
- PLUVICTO 1,000MBq/mL (27 mCi/mL), lutetium Lu 177 vipivotide tetraxetan injection, 9.2 mL Single-dose vial
- ManufacturerAdvanced Accelerator Appllications USA, Inc., 57 E. Willow Street NJ 07041, Milburn, USA, NDC 69488-010-61
- Lot codes and dates
- Lot # LPS230729B-16
- Exp 8/3/2023 at 10
00amLPS230804B-16
- Exp 8/9/2023 at 1000am
- Amount recalled
- 10
Where it was sold
- Nationwide
Why it was recalled
Labeling: Incorrect or Missing Lot and/or Exp Date: vials were labeled with the incorrect lot number and expiration date
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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