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
Status | Ongoing |
Mandated? | Voluntary: Firm initiated |
Recall Number | D-0202-2025 |
Event ID | 96033 |
Brand | GLIPIZIDE |
Generic Name | GLIPIZIDE |
Manufacturer | GLIPIZIDE |
Active Substance | GLIPIZIDE |
Drug Route | ORAL |
Distribution | Nationwide in the USA |
Quantity | 2,028 units (cartons of 30 individual unit doses) |
Recall Reason | Failed Dissolution Specifications: |
Drug Classification | Class II |
Drug Code Info | 20250122 |
Product NDC | 60687-480 |
Product NUI | N0000175608 M0020795 |
Pharma Class (EPC) | Sulfonylurea [EPC] |
Pharma Class (CS) | Sulfonylurea Compounds [CS] |
Recall Initiation Date | 20241217 |
Report Date | 20250122 |
Classification Date | 20250116 |
Address | 2550 John Glenn Ave Ste A Columbus, OH 43217-1188 United States |
Recalling Firm | Amerisource Health Services LLC |
Initial Notification | Letter |
Unique Ingredient Identifier | X7WDT95N5C |
Drug Application Number | ANDA206928 |
Structured Product Labeling (SPL ID) | 00b5027a-4427-16fd-e063-6294a90a4a13 |
Structured Product Labeling (SPL Set ID) | 9cc4b247-d211-4b5e-ba2c-b68848631c2a |
Similar To |