FDA Drug recall D-1117-2019
Losartan Potassium / Hydrochlorothiazide Tablets, USP 50mg/12.5mg, a) 30-count (NDC: 13668-116-30), b) 90-count (NDC: 13668-116-90), c) 100…
- FDA Drug
- Class II
- ongoing
- Published 2019-04-17
On 2019-04-17 the FDA classified a Class II recall of Losartan Potassium / Hydrochlorothiazide Tablets, USP 50mg/12.5mg, a) 30-count (NDC: 13668-116-30), b) 90-count (NDC: 13668-116-90), c) 100… by Torrent Pharma, citing CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1117-2019 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2019-02-28 |
| Published | 2019-04-17 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Torrent Pharma |
| Distribution | US |
Product
Losartan Potassium / Hydrochlorothiazide Tablets, USP 50mg/12.5mg, a) 30-count (NDC: 13668-116-30), b) 90-count (NDC: 13668-116-90), c) 1000-count (NDC: 13668-116-10) per bottle , Rx only, Manufactured by: Torrent Pharmaceuticals LTD, Indrad-382 721, Dist. Mehsana India. For: Torrent Pharma, Inc, 150 Allen Road, Suite 102, Basking Ridge, NJ
Reason
CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level.
Identifiers
| code_info | Count, lots, expiry: [30-count bottle] Lot BEF7D017,exp 6/30/2020 [90-count bottle] Lots BEF7D010, BEF7D011, exp 4/30/2…Count, lots, expiry: [30-count bottle] Lot BEF7D017,exp 6/30/2020 [90-count bottle] Lots BEF7D010, BEF7D011, exp 4/30/2020; Lot BEF7D018, exp 6/30/2020; Lot BEF7D009, exp 4/30/2020; Lots 4P02E002, 4P02E003, 4P02E004, exp 1/31/2021; [1000-count bottle] Lots BEF7D008, BEF7D012, BEF7D013, exp 4/30/2020; Lot BEF7D022, exp 8/31/2020; Lot BEF7D049, exp 11/30/2020; Lots 4P02E005, 4P02E006, exp 1/31/2021 |
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Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1117-2019%22
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