Product Safety Recalls

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ZILEUTON Recall D-1150-2022

Description: Zileuton Extended-Release Tablets, 600 mg, 120-count bottle, Rx only, Manufactured for Lupin Pharmaceuticals, Inc., Baltimore, MD 21202 by Lupin Limited, Nagpur-441108, India, NDC 68180-169-16

ZILEUTON Recall D-1150-2022 Information

Mandated?Voluntary: Firm initiated
Recall NumberD-1150-2022
Event ID90415
Generic NameZILEUTON
Original Package?1
Active SubstanceZILEUTON
Drug RouteORAL
DistributionProduct was distributed to 10 wholesalers/distributors and one mail order account who may have further distributed the product nationwide.
Quantity3,216 bottles
Recall ReasonFailed Dissolution Specifications: Out of specification test results observed in dissolution testing during long term stability study.
Drug ClassificationClass II
Drug Code Info20220622
Product NDC68180-169
Product NUIN0000175956 N0000175955 N0000008683
Pharma Class (PE)Decreased Leukotriene Production [PE]
Pharma Class (EPC)5-Lipoxygenase Inhibitor [EPC]
Recall Initiation Date20220610
Report Date20220622
Classification Date20220615
AddressHarborplace Tower111 S Calvert St Fl 21st
Baltimore, MD 21202-6174
United States
Recalling FirmLupin Pharmaceuticals Inc.
Initial Notification Letter
Unique Ingredient IdentifierV1L22WVE2S
Drug Application NumberANDA211972
Structured Product Labeling (SPL ID)5ccc51b9-399b-4c7e-b2e4-1bde256a0aee
Structured Product Labeling (SPL Set ID)cf392f79-2276-4fe1-8fa8-74afd5150f73
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