HYDROCHLOROTHIAZIDE Recall D-1164-2022
Description: Losartan potassium & Hydrochlorothiazide Tablets 100 mg/25 mg, 30, 90 & 1000 count NDC # 33342-052-07, NDC #33342-052-10 & NDC # 33342-052-44, Rx Only, MFR: Macleods Pharma USA, Inc. Plainsboro, NJ 08536
HYDROCHLOROTHIAZIDE Recall D-1164-2022 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-1164-2022 |
| Event ID | 90426 |
| Brand | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE |
| Generic Name | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE |
| Manufacturer | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE |
| Original Package? | 1 |
| Active Substance | HYDROCHLOROTHIAZIDE LOSARTAN POTASSIUM |
| Drug Route | ORAL |
| Distribution | Product was distributed nationwide. |
| Quantity | 84/1000 count bottles |
| Recall Reason | CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits |
| Drug Classification | Class II |
| Drug Code Info | 20220706 |
| Product NDC | 33342-050 33342-051 33342-052 |
| Product NUI | N0000175359 N0000175419 M0471776 |
| Drug UPC | 0333342051448 0333342051103 0333342051073 |
| Pharma Class (PE) | Increased Diuresis [PE] |
| Pharma Class (EPC) | Thiazide Diuretic [EPC] |
| Pharma Class (CS) | Thiazides [CS] |
| Recall Initiation Date | 20220610 |
| Report Date | 20220706 |
| Classification Date | 20220627 |
| Address | 666 Plainsboro Rd Bldg 200 Ste 230 Plainsboro, NJ 08536-0009 United States |
| Recalling Firm | Macleods Pharma Usa Inc |
| Initial Notification | Letter |
| Unique Ingredient Identifier | 0J48LPH2TH 3ST302B24A |
| Drug Application Number | ANDA202289 |
| Structured Product Labeling (SPL ID) | d5579695-0912-403b-9a85-33522bc98112 |
| Structured Product Labeling (SPL Set ID) | a04b5622-2c49-4d61-92b1-5dc523af7a24 |
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