Product Safety Recalls

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GLYCOPYRROLATE Recall D-0091-2023

Description: Glycopyrrolate Tablets, USP, 1 mg, 50 Tablets (5x10) Unit Dose carton, Rx Only, Manufactured for: AvKARE Pulaski, TN 38478, NDC 50268-363-15

GLYCOPYRROLATE Recall D-0091-2023 Information

Mandated?Voluntary: Firm initiated
Recall NumberD-0091-2023
Event ID91390
Drug RouteORAL
DistributionUSA Nationwide
Quantity1237 cartons
Recall ReasonFailed impurities/degradation specifications: Out of specification for unknown impurities.
Drug ClassificationClass II
Drug Code Info20230104
Product NDC50268-363
Recall Initiation Date20221222
Report Date20230104
Classification Date20221228
Address615 N 1st St
Pulaski, TN 38478-2403
United States
Recalling FirmAVKARE LLC
Initial Notification Letter
Unique Ingredient IdentifierV92SO9WP2I
Drug Application NumberANDA202675
Structured Product Labeling (SPL ID)df2243cd-68f0-71d6-e053-2995a90ac9ba
Structured Product Labeling (SPL Set ID)bd497783-e2d1-130c-e053-2995a90a7fb9
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