FDA Drug recall D-1081-2019
Losartan 50mg Tablet, 30 count each blister card
- FDA Drug
- Class II
- terminated
- Published 2019-04-17
On 2019-04-17 the FDA classified a Class II recall of Losartan 50mg Tablet, 30 count each blister card by Remedyrepack, citing CGMP Deviations; Detection of trace amounts of an unexpected impurity found in an active pharmaceutical ingredient (API) - N-Methylnitrosobutyric acid (NMBA).
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1081-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-03-14 |
| Published | 2019-04-17 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Remedyrepack |
| Distribution | FL |
Product
Losartan 50mg Tablet, 30 count each blister card.
Reason
CGMP Deviations; Detection of trace amounts of an unexpected impurity found in an active pharmaceutical ingredient (API) - N-Methylnitrosobutyric acid (NMBA).
Identifiers
| code_info | 70518-0588-01, Lot #: J0328416-101518, Exp. Date: 10/2019 |
|---|
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-1081-2019%22
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