NETSPOT (kit for the preparation of Ga 68 dotatate injection) 40 mcg dotatate, kit contains Vial 1 (Reaction vial with l
Summary
The FDA issued a Class III for NETSPOT (kit for the preparation of Ga 68 dotatate injection) 40 mcg dotatate, k by Advanced Accelerator Applications USA, Inc.. Reason: Subpotent Drug: low out-of-specification results for Vial 1 assay obtained during stability studies..
Details
Source
Drug Recall
External ID
D-0747-2022
Action Date
2022-04-13
Status
Terminated
Category
drug
Product Description
NETSPOT (kit for the preparation of Ga 68 dotatate injection) 40 mcg dotatate, kit contains Vial 1 (Reaction vial with lyophilized powder), 1 Single dose vial, consisting of 40 mcg of dotate, 5 mcg of 1,10-phenanthroline, 6 mcg of Gentisic acid, 20 mg of D-Mannitol, and Nitrogen; and Vial 2, 1 Single dose vial of reaction buffer, Rx Only, Manufactured for: Advanced Accelerator Applications USA, Inc., by: Gipharma S.r.l., Strada Crescentino snc, 13040 Saluggia (Vc), Italy, NDC 69488-001-40
Lot/Code Info: Lot # (Vial 1)/kit: (F03221004 vial) in kit PG1921014, PG1921015, Exp 16-Mar-2022; (F03221005 vial) in kit PG1921016, PG1921017, Exp 18-Mar-2022; (F03221006 vial) in kit PG1921018, PG1921019, Exp 11-May-2022; (F03221007 vial) in kit PG1921020, PG1921021, Exp 04-Aug-2022
Quantity Affected: 14,089 kits
Reason for Recall
Subpotent Drug: low out-of-specification results for Vial 1 assay obtained during stability studies.
Distribution
Nationwide in the USA and Puerto Rico
Type: Voluntary: Firm initiated
Recall Initiated: 2022-03-18
Company
Millburn, NJ
Context & Analysis
This is a Class III recall. Class III recalls involve products unlikely to cause adverse health consequences, but that violate FDA regulations.
This was one of 47 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Advanced Accelerator Applications USA, Inc. has 3 FDA actions in our database, including 3 recalls.
Frequently Asked Questions
What is a Class III recall?
A Class III recall involves products that are unlikely to cause adverse health effects but violate FDA labeling or manufacturing regulations.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Advanced Accelerator Applications USA, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Advanced Accelerator Applications USA, Inc. have FDA actions?
Advanced Accelerator Applications USA, Inc. has 3 FDA actions in our database, including 3 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0747-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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