Class II
Terminated
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.
- Recall Initiated
- January 10, 2020
- Posted
- January 29, 2020
- Recall Number
- D-0799-2020
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 4295 Kits
- Firm Location
- Millburn, NJ, United States
Reason for Recall
Defective Container: loose aluminum cap crimp for the dilution buffer vial present in the NETSPOT Kit (vial 2).
Distribution
Nationwide in the US and Canada
Lot / Code Info
Lot #: PG1919025, Exp. 07/11/2020; PG1919026, PG1919027, Exp. 07/16/2020.
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