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.
Reported: January 29, 2020 Initiated: January 10, 2020 #D-0799-2020
Product Description
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.
Reason for Recall
Defective Container: loose aluminum cap crimp for the dilution buffer vial present in the NETSPOT Kit (vial 2).
Details
- Recalling Firm
- Advanced Accelerator Applications USA, Inc.
- Units Affected
- 4295 Kits
- Distribution
- Nationwide in the US and Canada
- Location
- Millburn, NJ
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Advanced Accelerator Applications USA, Inc.. Units affected: 4295 Kits.
Why was this product recalled? ▼
Defective Container: loose aluminum cap crimp for the dilution buffer vial present in the NETSPOT Kit (vial 2).
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on January 29, 2020. Severity: Moderate. Recall number: D-0799-2020.
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