HYDROCHLOROTHIAZIDE Recall D-0199-2024
Description: Triamterene and Hydrochlorothiazide Capsules, USP, 37.5 mg/25 mg, 100 capsules per bottle, Rx Only, Distributed by: Lannett Company, Inc, Philadelphia, PA 19136. NDC 0527-1632-01
HYDROCHLOROTHIAZIDE Recall D-0199-2024 Information
| Status | Completed |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-0199-2024 |
| Event ID | 89450 |
| Brand | TRIAMTERENE AND HYDROCHLOROTHIAZIDE |
| Generic Name | TRIAMTERENE AND HYDROCHLOROTHIAZIDE |
| Manufacturer | TRIAMTERENE AND HYDROCHLOROTHIAZIDE |
| Original Package? | 1 |
| Active Substance | HYDROCHLOROTHIAZIDE TRIAMTERENE |
| Drug Route | ORAL |
| Distribution | Nationwide USA |
| Quantity | 2 units |
| Recall Reason | CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions. |
| Drug Classification | Class II |
| Drug Code Info | 20240103 |
| Product NDC | 0527-1632 |
| Product NUI | N0000175359 N0000175419 M0471776 |
| Pharma Class (PE) | Increased Diuresis [PE] |
| Pharma Class (EPC) | Thiazide Diuretic [EPC] |
| Pharma Class (CS) | Thiazides [CS] |
| Recall Initiation Date | 20220126 |
| Report Date | 20240103 |
| Classification Date | 20231226 |
| Address | 7200 Cardinal Pl W Dublin, OH 43017-1094 United States |
| Recalling Firm | CARDINAL HEALTHCARE |
| Initial Notification | Letter |
| Unique Ingredient Identifier | 0J48LPH2TH WS821Z52LQ |
| Drug Application Number | ANDA201407 |
| Structured Product Labeling (SPL ID) | 4d422902-e50b-4596-a753-5d5a9b29b209 |
| Structured Product Labeling (SPL Set ID) | b23d4978-0d47-457a-8176-0e8c567d5dd1 |
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