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NEOMYCIN SULFATE Recall D-1473-2022

Description: Neomycin Sulfate Tablets, USP 500 mg , 100-count bottles, Rx only, Distributed by: TEVA PHARMACEUTICALS USA, INC North Wales, PA 19454, NDC 0093-1177-01

NEOMYCIN SULFATE Recall D-1473-2022 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberD-1473-2022
Event ID90792
BrandNEOMYCIN SULFATE
Generic NameNEOMYCIN SULFATE
ManufacturerNEOMYCIN SULFATE
Original Package?1
Active SubstanceNEOMYCIN SULFATE
Drug RouteORAL
DistributionNationwide within the United States
Recall ReasonCGMP Deviations: A foreign matter identified as teflon was found in the Active Pharmaceutical Ingredient (API) used in the manufacture of Neomycin Sulfate Tablets, USP 500 mg.
Drug ClassificationClass II
Drug Code Info20220907
Product NDC0093-1177
Drug UPC0300931177018
Recall Initiation Date20220823
Report Date20220907
Classification Date20220830
Address400 Interpace Pkwy Bldg A
Parsippany, NJ 07054-1120
United States
Recalling FirmTeva Pharmaceuticals USA Inc
Initial Notification Letter
Unique Ingredient Identifier057Y626693
Drug Application NumberANDA060304
Structured Product Labeling (SPL ID)941cf1b7-9d5b-4c06-9f4e-24c2f9e7c457
Structured Product Labeling (SPL Set ID)777dbfab-f83e-4738-ae1e-78619a9f82a7
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