HYDROCHLOROTHIAZIDE Recall D-0837-2022
Description: Losartan Potassium & Hydrochlorothiazide Tablets, USP, 100 mg/12.5 mg, a) 30-count bottles (NDC# 33342-051-07), b) 90-count bottles (NDC # 33342-051-10) c) 1000-count bottles (NDC # 33342-051-44), Rx Only, MFR: Macleods Pharma USA, Inc. Plainsboro, NJ 08536
HYDROCHLOROTHIAZIDE Recall D-0837-2022 Information
Status | Ongoing |
Mandated? | Voluntary: Firm initiated |
Recall Number | D-0837-2022 |
Event ID | 90037 |
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. |
Recall Reason | CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits |
Drug Classification | Class II |
Drug Code Info | 20220511 |
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 | 20220415 |
Report Date | 20220511 |
Classification Date | 20220503 |
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 |
Similar To |