FDA Drug recall D-0359-2019
Sandoz Losartan Potassium and Hydrochlorothiazide Tablets, USP 100 mg/25 mg, 1000-count bottles, Rx Only, Finished Drug Product Manufacture…
- FDA Drug
- Class II
- ongoing
- Published 2018-12-05
On 2018-12-05 the FDA classified a Class II recall of Sandoz Losartan Potassium and Hydrochlorothiazide Tablets, USP 100 mg/25 mg, 1000-count bottles, Rx Only, Finished Drug Product Manufacture… by Sandoz, citing CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodiethylamine (NDEA) contained in the API used to manufacture the product above the interim acceptable daily intak….
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0359-2019 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2018-11-01 |
| Published | 2018-12-05 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Sandoz |
| Distribution | OH, PR |
Product
Sandoz Losartan Potassium and Hydrochlorothiazide Tablets, USP 100 mg/25 mg, 1000-count bottles, Rx Only, Finished Drug Product Manufactured by: Lek Pharmaceuticals d.d. SI-1526 Ljubljana,Sovenia for Sandoz Inc., Princeton, NJ 08540, NDC 0781-5207-10.
Reason
CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodiethylamine (NDEA) contained in the API used to manufacture the product above the interim acceptable daily intake level of 0.083 parts per million.
Identifiers
| code_info | Lot #: JB8912; Exp. 06/2020 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: ongoing.
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Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0359-2019%22
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