FDA Drug recall D-1283-2019
Losartan Potassium Tablets USP 25 mg 90 count bottle NDC 60429-316-90 Rx only GSMS Incorporated
- FDA Drug
- Class II
- terminated
- Published 2019-05-29
On 2019-05-29 the FDA classified a Class II recall of Losartan Potassium Tablets USP 25 mg 90 count bottle NDC 60429-316-90 Rx only GSMS Incorporated by Golden State Medical Supply, 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 at the manuf….
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1283-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-05-01 |
| Published | 2019-05-29 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Golden State Medical Supply |
| Distribution | IL, MI, MN, PA, TN, TX |
Product
Losartan Potassium Tablets USP 25 mg 90 count bottle NDC 60429-316-90 Rx only GSMS Incorporated
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 at the manufacturer
Identifiers
| code_info | GS015172 exp 06/2019 GS017634 02/2020, GS017653 exp 02/2020, GS017980 exp 02/2020, GS017276 exp 02/2020, GS017045 exp 02/2020,GS016726 exp 02/2020, |
|---|
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-1283-2019%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.