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GENTAMICIN SULFATE Recall D-0687-2022

Description: Gentamicin Sulfate Ointment USP 0.1%, packaged as a) 15 grams tube, NDC 52565-090-15; b) 30 grams tube, NDC 52565-090-30, Rx Only, Manufactured by: Teligent Pharma, Inc., Buena, NJ 08310.

GENTAMICIN SULFATE Recall D-0687-2022 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberD-0687-2022
Event ID89798
BrandGENTAMICIN SULFATE
Generic NameGENTAMICIN SULFATE
ManufacturerGENTAMICIN SULFATE
Original Package?1
Active SubstanceGENTAMICIN SULFATE
Drug RouteTOPICAL
DistributionNationwide in the USA and Puerto Rico
Quantity43,956 tubes
Recall ReasoncGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.
Drug ClassificationClass II
Drug Code Info20220330
Product NDC52565-090
Recall Initiation Date20220315
Report Date20220330
Classification Date20220321
Address105 Lincoln Avenue
Buena, NJ 08310
United States
Recalling FirmTeligent Pharma, Inc.
Initial Notification Letter
Unique Ingredient Identifier8X7386QRLV
Drug Application NumberANDA209233
Structured Product Labeling (SPL ID)bab39bb1-5c1b-498e-889a-18915032086b
Structured Product Labeling (SPL Set ID)e2fd1885-afad-dcc8-ad64-27d45f63c00f
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