FDA Drug recall D-1161-2022
Losartan Potassium Tablets, USP 25 mg, 90 Tablets bottles, Rx Only Marketed and Packaged By: PD-Rx Pharmaceuticals, Inc
- FDA Drug
- Class II
- terminated
- Published 2022-07-06
On 2022-07-06 the FDA classified a Class II recall of Losartan Potassium Tablets, USP 25 mg, 90 Tablets bottles, Rx Only Marketed and Packaged By: PD-Rx Pharmaceuticals, Inc by Pd Rx Pharmaceuticals, citing CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1161-2022 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2022-06-06 |
| Published | 2022-07-06 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Pd Rx Pharmaceuticals |
| Distribution | US |
Product
Losartan Potassium Tablets, USP 25 mg, 90 Tablets bottles, Rx Only Marketed and Packaged By: PD-Rx Pharmaceuticals, Inc. Oklahoma City, OK 73127 Manufactured by: Vivimed Life Sciences Private Limited, Plot No. 101, 102, 107 & 108 SIDCO Pharmaceutical Complex, Alathur, Kanchipuram-603 110, Tamilnadu, India NDC 72789-163-90 UPC 3 72789 16390 1
Reason
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
Identifiers
| upc | 372789163901 |
|---|---|
| ndc | 72789-163-90 |
| ndc | 72789-164-90 |
| ndc | 72789-165-90 |
| code_info | Lots: D21C18 Exp. 09/30/22; E21A28 Exp. 09/30/22; E21C04 Exp. 09/30/22; E21D59 Exp. 09/30/22; G21B65 Exp. 09/30/22; H21…Lots: D21C18 Exp. 09/30/22; E21A28 Exp. 09/30/22; E21C04 Exp. 09/30/22; E21D59 Exp. 09/30/22; G21B65 Exp. 09/30/22; H21A12 Exp. 09/30/22; H21D42 Exp. 09/30/22; K21D19 Exp. 10/31/22; A22A73 Exp. 10/31/22 |
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-1161-2022%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.