FDA Drug recall D-0971-2022
Losartan Pot./HCTZ 100/12.5 mg Packaged and Distributed By: Direct Rx Dawsonville, GA 30534 Mfg For: Lupin Pharmaceuticals, Inc
- FDA Drug
- Class II
- terminated
- Published 2022-06-08
On 2022-06-08 the FDA classified a Class II recall of Losartan Pot./HCTZ 100/12.5 mg Packaged and Distributed By: Direct Rx Dawsonville, GA 30534 Mfg For: Lupin Pharmaceuticals, Inc 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-0971-2022 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2022-05-05 |
| Published | 2022-06-08 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Direct Rx |
| Distribution | AL, FL, GA, LA |
Product
Losartan Pot./HCTZ 100/12.5 mg Packaged and Distributed By: Direct Rx Dawsonville, GA 30534 Mfg For: Lupin Pharmaceuticals, Inc. Baltimore, MD 21202 a) 30 Tabs NDC 72189-167-30; b) 90 Tabs NDC 72189-167-90
Reason
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
Identifiers
| ndc | 72189-012-90 |
|---|---|
| ndc | 72189-098-90 |
| ndc | 72189-129-90 |
| ndc | 72189-129-30 |
| ndc | 72189-139-30 |
| ndc | 72189-139-90 |
| ndc | 72189-167-30 |
| ndc | 72189-167-90 |
| code_info | a) 30-count bottles- Lot: 11MY2103 Exp. 11/30/22 Lot: 05JA2106 Exp. 6/30/22 b) 90-count bottles- Lot: 20…a) 30-count bottles- Lot: 11MY2103 Exp. 11/30/22 Lot: 05JA2106 Exp. 6/30/22 b) 90-count bottles- Lot: 20MY2115 Exp. 11/30/22 Lot: 22JU2118 Exp. 12/31/22 Lot: 29JY2113 Exp. 12/31/22 Lot: 13SE2113 Exp. 2/28/23 Lot: 05JA2106 Exp. 6/30/22 |
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-0971-2022%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.