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GLIPIZIDE Recall D-0202-2025

Description: glipiZIDE, Extended-Release Tablets, 2.5 mg, 30-count (3x10 blister cards) carton, Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217, Carton NDC: 60687-480-21, Unit Dose NDC: 60687-480-11

GLIPIZIDE Recall D-0202-2025 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberD-0202-2025
Event ID96033
BrandGLIPIZIDE
Generic NameGLIPIZIDE
ManufacturerGLIPIZIDE
Active SubstanceGLIPIZIDE
Drug RouteORAL
DistributionNationwide in the USA
Quantity2,028 units (cartons of 30 individual unit doses)
Recall ReasonFailed Dissolution Specifications:
Drug ClassificationClass II
Drug Code Info20250122
Product NDC60687-480
Product NUIN0000175608 M0020795
Pharma Class (EPC)Sulfonylurea [EPC]
Pharma Class (CS)Sulfonylurea Compounds [CS]
Recall Initiation Date20241217
Report Date20250122
Classification Date20250116
Address2550 John Glenn Ave Ste A
Columbus, OH 43217-1188
United States
Recalling FirmAmerisource Health Services LLC
Initial Notification Letter
Unique Ingredient IdentifierX7WDT95N5C
Drug Application NumberANDA206928
Structured Product Labeling (SPL ID)00b5027a-4427-16fd-e063-6294a90a4a13
Structured Product Labeling (SPL Set ID)9cc4b247-d211-4b5e-ba2c-b68848631c2a
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