HYDROCHLOROTHIAZIDE Recall D-0841-2022
Description: Losartan Potassium and Hydrochlorothiazide Tablets USP, 50 mg/12.5 mg a) 30-count bottles (NDC# 68180-215-06) b) 90-count bottles (NDC# 68180-215-09), Rx Only, Manufactured By: Lupin Limited, Pithampur, India, MFG For: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202, USA.
HYDROCHLOROTHIAZIDE Recall D-0841-2022 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-0841-2022 |
| Event ID | 89916 |
| 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 | 1,214,016 bottles |
| Recall Reason | CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits |
| Drug Classification | Class II |
| Drug Code Info | 20220511 |
| Product NDC | 68180-215 68180-216 68180-217 |
| Product NUI | N0000175359 N0000175419 M0471776 |
| Drug UPC | 0006018000070 0368180216063 0368180215066 |
| Pharma Class (PE) | Increased Diuresis [PE] |
| Pharma Class (EPC) | Thiazide Diuretic [EPC] |
| Pharma Class (CS) | Thiazides [CS] |
| Recall Initiation Date | 20220331 |
| Report Date | 20220511 |
| Classification Date | 20220503 |
| Address | Harborplace Tower111 S Calvert St Fl 21st Baltimore, MD 21202-6174 United States |
| Recalling Firm | Lupin Pharmaceuticals Inc. |
| Initial Notification | Letter |
| Unique Ingredient Identifier | 0J48LPH2TH 3ST302B24A |
| Drug Application Number | ANDA078245 |
| Structured Product Labeling (SPL ID) | d6b52688-486b-4256-b9f7-667ec6163dd3 |
| Structured Product Labeling (SPL Set ID) | ee1eaaf6-050b-48af-942b-5e3451edc164 |
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