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INOTERSEN SODIUM Recall D-1166-2022

Description: Tegsedi (inotersen) Injection 284 mg/1.5 mL, Rx Only, Sterile solution for Subcutaneous Use, 4 prefilled syringes, each containing 284 mg of inotersen, (equivalent to 300 mg inotersen sodium in 1.5 ml of solution), Distributed by Sobi, Inc. Inc Waltham MA 02451, NDC: 72126-007-01

INOTERSEN SODIUM Recall D-1166-2022 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberD-1166-2022
Event ID90245
BrandTEGSEDI
Generic NameINOTERSEN
ManufacturerINOTERSEN
Original Package?1
Active SubstanceINOTERSEN SODIUM
Drug RouteSUBCUTANEOUS
DistributionKY, USA
Quantity450 cartons
Recall ReasonSuperpotent: High Out of specification (OOS) test result for percent label claim (%LC).
Drug ClassificationClass I
Drug Code Info20220706
Product NDC72126-007
Recall Initiation Date20220523
Report Date20220706
Classification Date20220627
Address2855 Gazelle Ct
Carlsbad, CA 92010-6670
United States
Recalling FirmAkcea Therapeutics, Inc.
Initial Notification E-Mail
Unique Ingredient Identifier950736UC77
Drug Application NumberNDA211172
Structured Product Labeling (SPL ID)096941de-9387-47b2-b717-918d2709ed37
Structured Product Labeling (SPL Set ID)8513207e-b55f-417b-9473-af785146a543
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