Recalls / Class III
Class IIID-0747-2022
Product
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
- Brand name
- Netspot
- Generic name
- 68ga-dotatate
- Route
- Intravenous
- NDC
- 69488-001
- FDA application
- NDA208547
- Affected 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
Why it was recalled
Subpotent Drug: low out-of-specification results for Vial 1 assay obtained during stability studies.
Recalling firm
- Firm
- Advanced Accelerator Applications USA, Inc.
- Manufacturer
- Advanced Accelerator Applications USA, Inc
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 57 E Willow St, Millburn, New Jersey 07041-1416
Distribution
- Quantity
- 14,089 kits
- Distribution pattern
- Nationwide in the USA and Puerto Rico
Timeline
- Recall initiated
- 2022-03-18
- FDA classified
- 2022-04-06
- Posted by FDA
- 2022-04-13
- Terminated
- 2023-01-04
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0747-2022. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.