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GLYCOPYRROLATE Recall D-0736-2022

Description: Glycopyrrolate Tablets, USP, 1 mg, 100-count bottle, Rx Only, Distributed by: Aurobindo Pharma USA, Inc., 279 Princeton-Hightstown Road, East Windsor, NJ 08520, NDC 13107-014-01.

GLYCOPYRROLATE Recall D-0736-2022 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberD-0736-2022
Event ID89869
BrandGLYCOPYRROLATE
Generic NameGLYCOPYRROLATE
ManufacturerGLYCOPYRROLATE
Original Package?1
Active SubstanceGLYCOPYRROLATE
Drug RouteORAL
DistributionNationwide in the USA and Puerto Rico
Quantity4080 bottles
Recall ReasonPresence of Foreign Substance: Complaint for pieces of glass discovered in a sealed bottle which came from equipment within the packaging room.
Drug ClassificationClass II
Drug Code Info20220406
Product NDC13107-014 13107-015
Recall Initiation Date20220317
Report Date20220406
Classification Date20220330
Address2400 US Highway 130
Dayton, NJ 08810-1519
United States
Recalling FirmAurolife Pharma, LLC
Initial Notification Letter
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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