FDA Drug recall D-1269-2019
Losartan Potassium and Hydrochlorothiazide Tablets, USP, 100mg/25mg, a) 30-count (NDC: 13668-118-30) b) 90-count (NDC: 13668-118-90), c) 10…
- FDA Drug
- Class II
- ongoing
- Published 2019-05-08
On 2019-05-08 the FDA classified a Class II recall of Losartan Potassium and Hydrochlorothiazide Tablets, USP, 100mg/25mg, a) 30-count (NDC: 13668-118-30) b) 90-count (NDC: 13668-118-90), c) 10… 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-1269-2019 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2019-04-18 |
| Published | 2019-05-08 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Torrent Pharma |
| Distribution | US |
Product
Losartan Potassium and Hydrochlorothiazide Tablets, USP, 100mg/25mg, a) 30-count (NDC: 13668-118-30) b) 90-count (NDC: 13668-118-90), c) 1000-count (NDC: 13668-118-10), per bottle, Rx only, Manufactured by: Torrent Pharmaceuticals LTD, Indrad-382 721, Dist. Mehsana India
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 BEF6D054, exp 8/31/2020; [90-count bottle] Lot BP04C092, exp 10/31/2019; Lot…Count, lots, expiry: [30-count bottle] Lot BEF6D054, exp 8/31/2020; [90-count bottle] Lot BP04C092, exp 10/31/2019; Lots BP04D012, BP04D013, exp 12/31/2019; Lots BEF6D012, BEF6D013, exp 3/31/2020; Lots BEF6D060, BEF6D061, BEF6D063, exp 9/30/2020; Lots BEF6D076, BEF6D077, BEF6D078, BEF6D079, exp 10/31/2020; Lots BEF6D100, BEF6D101, BEF6D102, exp 11/30/2020; Lots BEF6E001, BEF6E002, BEF6E003, BEF6E004, BEF6E008, BEF6E009, BEF6E010, BEF6E011, BEF6E012, exp 12/31/2020 |
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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-1269-2019%22
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