OLMESARTAN MEDOXOMIL Recall D-1503-2014
Description: Benicar HCT Tablets (olmesartan medoxomil, hydrochlorothiazide) 20 mg/12.5 mg, 30 count bottles, Rx Only, Manufactured for: Daiichi Sankyo, Inc., Parsippany, NJ 07054 --- NDC 65597-105-30
OLMESARTAN MEDOXOMIL Recall D-1503-2014 Information
| Status | Terminated |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-1503-2014 |
| Event ID | 68793 |
| Brand | BENICAR HCT |
| Generic Name | OLMESARTAN MEDOXOMIL-HYDROCHLOROTHIAZIDE |
| Manufacturer | OLMESARTAN MEDOXOMIL-HYDROCHLOROTHIAZIDE |
| Original Package? | 1 |
| Active Substance | OLMESARTAN MEDOXOMIL HYDROCHLOROTHIAZIDE |
| Drug Route | ORAL |
| Distribution | Nationwide |
| Quantity | 108 bottles |
| Recall Reason | Temperature Abuse; various products were not stored at Controlled Room Temperature as per USP guidelines during shipping |
| Drug Classification | Class II |
| Drug Code Info | 20140806 |
| Product NDC | 65597-105 65597-106 65597-107 |
| Product NUI | N0000175359 N0000175419 M0471776 |
| Drug UPC | 0365597105300 0365597106307 0365597107304 |
| Pharma Class (PE) | Increased Diuresis [PE] |
| Pharma Class (EPC) | Thiazide Diuretic [EPC] |
| Pharma Class (CS) | Thiazides [CS] |
| Recall Initiation Date | 20140712 |
| Report Date | 20140806 |
| Termination Date | 20150316 |
| Classification Date | 20140731 |
| Address | 399 Thornall St Edison, NJ 08837-2236 United States |
| Recalling Firm | Daiichi Sankyo Pharma Development |
| Initial Notification | Telephone |
| Unique Ingredient Identifier | 6M97XTV3HD 0J48LPH2TH |
| Drug Application Number | NDA021532 |
| Structured Product Labeling (SPL ID) | 487a5b07-575c-43b5-9802-6127c9a63ce6 |
| Structured Product Labeling (SPL Set ID) | 6bbc032a-3cc4-4b1d-8124-1784214a2821 |
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