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
Reported: August 23, 2023 Initiated: August 7, 2023 #D-1085-2023
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
Reason for Recall
Labeling: Incorrect or Missing Lot and/or Exp Date: vials were labeled with the incorrect lot number and expiration date
Details
- Recalling Firm
- Advanced Accelerator Applications USA, Inc.
- Units Affected
- 10
- Distribution
- Distributed Nationwide in the USA
- Location
- Millburn, NJ
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Advanced Accelerator Applications USA, Inc.. Units affected: 10.
Why was this product recalled? ▼
Labeling: Incorrect or Missing Lot and/or Exp Date: vials were labeled with the incorrect lot number and expiration date
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on August 23, 2023. Severity: Low. Recall number: D-1085-2023.
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