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LEVOTHYROXINE Recall D-1300-2020

Description: NP Thyroid 90, Thyroid Tablets, USP, 1 & 1/2 grain (90 mg), 100-count bottles, Rx Only, Manufactured For: Acella Pharmaceuticals, LLC, Alpharetta, GA 30005, NDC 42192-331-01.

LEVOTHYROXINE Recall D-1300-2020 Information

StatusCompleted
Mandated?Voluntary: Firm initiated
Recall NumberD-1300-2020
Event ID85721
BrandNP THYROID 90
Generic NameLEVOTHYROXINE, LIOTHYRONINE
ManufacturerLEVOTHYROXINE, LIOTHYRONINE
Original Package?1
Active SubstanceLEVOTHYROXINE LIOTHYRONINE
Drug RouteORAL
DistributionDistributed Nationwide in the US and Puerto Rico
Quantity49,128 bottles
Recall ReasonSuperpotent Drug.
Drug ClassificationClass I
Drug Code Info20200610
Product NDC42192-331
Product NUIN0000175945 M0021504 N0000175946
Drug UPC0342192331013
Pharma Class (EPC)l-Thyroxine [EPC]
Pharma Class (CS)Thyroxine [CS]
Recall Initiation Date20200522
Report Date20200610
Classification Date20200608
Address1880 Mcfarland Pkwy Ste 110-B
Alpharetta, GA 30005
United States
Recalling FirmAcella Pharmaceuticals, LLC
Initial Notification Press Release
Unique Ingredient IdentifierQ51BO43MG4 06LU7C9H1V
Structured Product Labeling (SPL ID)d60cf708-0b63-4b8b-b5eb-736bb4165d1f
Structured Product Labeling (SPL Set ID)dac99035-9098-4710-bf55-c46889ffc282
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