Recalls / Class II
Class IID-0799-2020
Product
NETSPOT, (kit for the preparation of Ga 68 dotatate injection) 40 mcg dotatate, For Intravenous Use Only, 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 #: PG1919025, Exp. 07/11/2020; PG1919026, PG1919027, Exp. 07/16/2020.
Why it was recalled
Defective Container: loose aluminum cap crimp for the dilution buffer vial present in the NETSPOT Kit (vial 2).
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
- 4295 Kits
- Distribution pattern
- Nationwide in the US and Canada
Timeline
- Recall initiated
- 2020-01-10
- FDA classified
- 2020-01-22
- Posted by FDA
- 2020-01-29
- Terminated
- 2023-07-21
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0799-2020. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.