FDA Drug recall D-0894-2022
Losartan Pot/HCTZ 50/12.5 mg 90 Tabs NDC 72189-297-90 Packaged and Distributed By: Direct Rx Dawsonville, GA 30534 Mfg
- FDA Drug
- Class II
- terminated
- Published 2022-06-01
On 2022-06-01 the FDA classified a Class II recall of Losartan Pot/HCTZ 50/12.5 mg 90 Tabs NDC 72189-297-90 Packaged and Distributed By: Direct Rx Dawsonville, GA 30534 Mfg by Direct Rx, citing CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits .
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0894-2022 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2022-05-11 |
| Published | 2022-06-01 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Direct Rx |
| Distribution | FL |
Product
Losartan Pot/HCTZ 50/12.5 mg 90 Tabs NDC 72189-297-90 Packaged and Distributed By: Direct Rx Dawsonville, GA 30534 Mfg. For Macleods Pharma USA, Inc. Plainsboro, NJ 08540
Reason
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits .
Identifiers
| ndc | 72189-297-90 |
|---|---|
| code_info | Lots: 19NO2108 Exp. 1/31/25; 19NO2114 Exp. 1/31/25; 22NO2126 Exp. 1/31/25 |
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-0894-2022%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.