FDA Drug recall D-1044-2019
Losartan Potassium Tablets USP 50 mg 50 Tablets (5x10) Unit Dose boxes, Rx Only, Manufactured for: AvKARE Inc
- FDA Drug
- Class II
- terminated
- Published 2019-03-27
On 2019-03-27 the FDA classified a Class II recall of Losartan Potassium Tablets USP 50 mg 50 Tablets (5x10) Unit Dose boxes, Rx Only, Manufactured for: AvKARE Inc by Avkare, citing CGMP Deviations: presence of an impurity, N-Methylnitrosobutyric acid (NMBA) was identified.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1044-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-03-05 |
| Published | 2019-03-27 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Avkare |
| Distribution | US |
Product
Losartan Potassium Tablets USP 50 mg 50 Tablets (5x10) Unit Dose boxes, Rx Only, Manufactured for: AvKARE Inc. Pulaski, TN 38478 ---- NDC 50268-517-15
Reason
CGMP Deviations: presence of an impurity, N-Methylnitrosobutyric acid (NMBA) was identified
Identifiers
| code_info | Lots: 20961 Exp. 09/2019; 20477 Exp. 08/2019 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1044-2019%22
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