PLUVICTO Injection Recalled for Incorrect Lot and Expiration Date Labels
PLUVICTO (lutetium Lu 177 vipivotide tetraxetan) injection vials were labeled with incorrect lot numbers and expiration dates. The manufacturer is recalling affected lots distributed nationwide.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is a Class III recall involving minor labeling errors where lot numbers and expiration dates were printed incorrectly on vials. No illnesses or injuries have been reported, and the hazard is limited to label information rather than product quality defect.
Plain-English summary
PLUVICTO (lutetium Lu 177 vipivotide tetraxetan) injection is a radioactive pharmaceutical product manufactured by Advanced Accelerator Applications USA, Inc. Certain vials distributed nationwide in the USA were found to have incorrect lot numbers and expiration dates printed on their labels.
The affected vials include Lot #LPS230729B-16 (expiration 8/3/2023 at 10:00am) and Lot #LPS230804B-16 (expiration 8/9/2023 at 10:00am). No illnesses or injuries related to this labeling issue have been reported.
Healthcare providers who have received these vials should verify the lot number and expiration date information against the actual product before administering to patients. Patients with questions about their medication should contact their healthcare provider.
The recalled product
- 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
- Manufacturer
- Advanced Accelerator Applications USA, Inc.
- Category
- Drug — Radiopharmaceutical
- Affected units
- 10
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- Lot # LPS230729B-16
- Exp 8/3/2023 at 10:00am
- LPS230804B-16
- Exp 8/9/2023 at 10:00am.
Distribution
Distributed nationwide across the United States.
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