TELMISARTAN Recall D-0285-2022
Description: Telmisartan and Hydrochlorothiazide Tablets, USP, 40 mg/12.5 mg, 30 count bottles, Rx only, Manufactured by: Torrent Pharmaceuticals LTD., Indrad-382 721, India. Manufactured for: Torrent Pharma Inc., Basking Ridge, NJ 07920. NDC: 13668-159-30
TELMISARTAN Recall D-0285-2022 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-0285-2022 |
| Event ID | 89141 |
| Brand | TELMISARTAN AND HYDROCHLORTHIAZIDE |
| Generic Name | TELMISARTAN AND HYDROCHLORTHIAZIDE |
| Manufacturer | TELMISARTAN AND HYDROCHLORTHIAZIDE |
| Original Package? | 1 |
| Active Substance | TELMISARTAN HYDROCHLOROTHIAZIDE |
| Drug Route | ORAL |
| Distribution | Nationwide USA |
| Quantity | 27,312 Bottles |
| Recall Reason | Superpotent; Hydrochlorothiazide |
| Drug Classification | Class III |
| Drug Code Info | 20211222 |
| Product NDC | 13668-159 13668-160 13668-161 |
| 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 | 20211201 |
| Report Date | 20211222 |
| Classification Date | 20211216 |
| Address | 150 Allen Rd Ste 102 Basking Ridge, NJ 07920-3856 United States |
| Recalling Firm | Torrent Pharma Inc. |
| Initial Notification | Letter |
| Unique Ingredient Identifier | 0J48LPH2TH U5SYW473RQ |
| Drug Application Number | ANDA201192 |
| Structured Product Labeling (SPL ID) | 963b3064-0950-541a-e053-2995a90ac443 |
| Structured Product Labeling (SPL Set ID) | 4ab13b8c-1110-477b-a6a3-ee93e33b9faa |
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