Product Safety Recalls

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TACROLIMUS Recall D-1304-2022

Description: Tacrolimus Ointment, 0.1%, For Dermatological Use Only, Not for Ophthalmic Use, Rx Only, a) 30 g tube, NDC 68462-534-35, b) 60 g tube, NDC 68462-534-65, c) 100 g tube, NDC 68462-534-94, Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430, Product of India.

TACROLIMUS Recall D-1304-2022 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberD-1304-2022
Event ID90550
BrandTACROLIMUS
Generic NameTACROLIMUS
ManufacturerTACROLIMUS
Original Package?1
Active SubstanceTACROLIMUS
Drug RouteTOPICAL
DistributionNationwide in the USA
Quantity654,756 tubes
Recall ReasonDefective Container: Tube split from side seam
Drug ClassificationClass III
Drug Code Info20220810
Product NDC68462-534
Drug UPC0368462534946
Recall Initiation Date20220711
Report Date20220810
Classification Date20220804
Address750 Corporate Dr
Mahwah, NJ 07430-2009
United States
Recalling FirmGlenmark Pharmaceuticals Inc., USA
Initial Notification Letter
Unique Ingredient IdentifierWM0HAQ4WNM
Drug Application NumberANDA210393
Structured Product Labeling (SPL ID)cc97f54d-975c-4807-92bd-3558c221dc05
Structured Product Labeling (SPL Set ID)c2d2e3a1-f346-4245-b445-6dd44e371180
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