Product Safety Recalls

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MOMETASONE FUROATE Recall D-1173-2022

Description: Mometasone Furoate, Topical Solution USP, 0.1 % Lotion, a) 30 ml-bottle (NDC 68462-385-37), b) 60 ml-bottle (NDC 68462-385-02), Rx only, Manufactured by: Glenmark Pharmaceuticals Limited, Baddi Himachal Pradesh 173205, Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah NJ 07430.

MOMETASONE FUROATE Recall D-1173-2022 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberD-1173-2022
Event ID90473
BrandMOMETASONE FUROATE
Generic NameMOMETASONE FUROATE
ManufacturerMOMETASONE FUROATE
Original Package?1
Active SubstanceMOMETASONE FUROATE
Drug RouteTOPICAL
DistributionNationwide in the USA
Quantity98, 307 packs
Recall ReasonDefective Container
Drug ClassificationClass III
Drug Code Info20220713
Product NDC68462-385
Drug UPC0368462385371
Recall Initiation Date20220616
Report Date20220713
Classification Date20220701
Address750 Corporate Dr
Mahwah, NJ 07430-2009
United States
Recalling FirmGlenmark Pharmaceuticals Inc., USA
Initial Notification Letter
Unique Ingredient Identifier04201GDN4R
Drug Application NumberANDA090506
Structured Product Labeling (SPL ID)126901b5-73a3-477a-81f2-61a373806f7f
Structured Product Labeling (SPL Set ID)96eafc06-0354-49ca-a684-a77bb2afc8f5
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