FDA Drug recall D-1456-2019
LOSARTAN POTASSIUM 100 mg TABLET BULK 90 count bottles, NDC 00591-3747-00
- FDA Drug
- Class II
- ongoing
- Published 2019-07-17
On 2019-07-17 the FDA classified a Class II recall of LOSARTAN POTASSIUM 100 mg TABLET BULK 90 count bottles, NDC 00591-3747-00 by Teva Pharmaceuticals Usa, citing CGMP Deviations: impurity for N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) detected in the active pharmaceutical ingredient (API) used to manufacture finished products.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1456-2019 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2019-06-06 |
| Published | 2019-07-17 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Teva Pharmaceuticals Usa |
| Distribution | US |
Product
LOSARTAN POTASSIUM 100 mg TABLET BULK 90 count bottles, NDC 00591-3747-00
Reason
CGMP Deviations: impurity for N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) detected in the active pharmaceutical ingredient (API) used to manufacture finished products.
Identifiers
| code_info | Arrow Malta (Teva) Bulk Product Lot # 1163892A, exp. date 01/2020 1163893A, exp. date 01/2020 1163894A, exp. date 01…Arrow Malta (Teva) Bulk Product Lot # 1163892A, exp. date 01/2020 1163893A, exp. date 01/2020 1163894A, exp. date 01/2020 1163895A, exp. date 01/2020 Golden State Medical Finished Product Lot # GS017042, exp. date 01/2020 GS017043, exp. date 01/2020 GS017044, exp. date 01/2020 GS017541, exp. date 01/2020 |
|---|
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-1456-2019%22
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