Product Safety Recalls

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Recall D-0747-2022

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

Recall D-0747-2022 Information

Mandated?Voluntary: Firm initiated
Recall NumberD-0747-2022
Event ID89885
Generic Name68GA-DOTATATE
Original Package?1
DistributionNationwide in the USA and Puerto Rico
Quantity14,089 kits
Recall ReasonSubpotent Drug: low out-of-specification results for Vial 1 assay obtained during stability studies.
Drug ClassificationClass III
Drug Code Info20220413
Product NDC69488-001
Recall Initiation Date20220318
Report Date20220413
Classification Date20220406
Address57 E Willow St
Millburn, NJ 07041-1416
United States
Recalling FirmAdvanced Accelerator Applications USA, Inc.
Initial Notification Letter
Drug Application NumberNDA208547
Structured Product Labeling (SPL ID)e9d3e09e-a97f-4b81-9b6c-83598e3f1e32
Structured Product Labeling (SPL Set ID)b2b3be70-17d8-4093-896c-f1c54a2cf242
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