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GLYCOPYRROLATE Recall D-0087-2023

Description: Glycopyrrolate Tablets, USP, 1 mg, 100 tablets, Rx Only, Distributed by: Aurobindo Pharma USA, Inc., East Windsor, NJ 08520, NDC 13107-014-01

GLYCOPYRROLATE Recall D-0087-2023 Information

Mandated?Voluntary: Firm initiated
Recall NumberD-0087-2023
Event ID91319
Original Package?1
Drug RouteORAL
DistributionNationwide in the USA and Puerto Rico.
Quantity7344 bottles
Recall ReasonFailed Impurities/Degradation Specifications
Drug ClassificationClass II
Drug Code Info20221228
Product NDC13107-014 13107-015
Recall Initiation Date20221216
Report Date20221228
Classification Date20221222
Address2400 US Highway 130
Dayton, NJ 08810-1519
United States
Recalling FirmAurolife Pharma, LLC
Unique Ingredient IdentifierV92SO9WP2I
Drug Application NumberANDA202675
Structured Product Labeling (SPL ID)4bbe80ee-835d-4e90-9b9c-24f6b1a535d6
Structured Product Labeling (SPL Set ID)677f8495-a870-45b6-bb65-75b449f040ce
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