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LEVOTHYROXINE SODIUM Recall D-0340-2023

Description: TIROSINT - SOL (levothyroxine sodium) Oral Solution, 75 microgram/mL; 6 pouches x 5 ampules, Rx Only; Manufactured for IBSA Pharma Inc. by: IBSA Institut Biochimique SA, 6912 Pazzallo, Switzerland; Distributed by: IBSA Pharma Inc., Parsippany, NJ 07054; NDC 71858-0120-5

LEVOTHYROXINE SODIUM Recall D-0340-2023 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberD-0340-2023
Event ID91556
BrandTIROSINT
Generic NameLEVOTHYROXINE SODIUM
ManufacturerLEVOTHYROXINE SODIUM
Original Package?1
Active SubstanceLEVOTHYROXINE SODIUM
Drug RouteORAL
DistributionNationwide in the USA.
Recall ReasonSubpotent Drug
Drug ClassificationClass I
Drug Code Info20230301
Product NDC71858-0105 71858-0110 71858-0112
Recall Initiation Date20230130
Report Date20230301
Classification Date20230221
Address8 Campus Dr Ste 201
Parsippany, NJ 07054-4409
United States
Recalling FirmIBSA PHARMA INC
Initial Notification Letter
Unique Ingredient Identifier9J765S329G
Drug Application NumberNDA206977
Structured Product Labeling (SPL ID)f1d5f04c-48ff-6a9f-e053-2a95a90a5f81
Structured Product Labeling (SPL Set ID)5d378add-f13d-40f2-99dc-0f2340ab44b7
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