FDA Drug recall D-0833-2022
Losartan Potassium Tablets, USP, 50 mg, a) 30-count bottles (NDC # 33342-045-07), b) 90-count bottles (NDC # 33342-045-10), c) 1000-count b…
- FDA Drug
- Class II
- terminated
- Published 2022-05-11
On 2022-05-11 the FDA classified a Class II recall of Losartan Potassium Tablets, USP, 50 mg, a) 30-count bottles (NDC # 33342-045-07), b) 90-count bottles (NDC # 33342-045-10), c) 1000-count b… by Macleods Pharma Usa, citing CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0833-2022 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2022-04-15 |
| Published | 2022-05-11 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Macleods Pharma Usa |
| Distribution | US |
Product
Losartan Potassium Tablets, USP, 50 mg, a) 30-count bottles (NDC # 33342-045-07), b) 90-count bottles (NDC # 33342-045-10), c) 1000-count bottles (NDC # 33342-045-44), Rx Only, MFR: Macleods Pharma USA, Inc. Plainsboro, NJ 08536
Reason
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
Identifiers
| ndc | 33342-044-10 |
|---|---|
| ndc | 33342-044-12 |
| ndc | 33342-044-07 |
| ndc | 33342-044-44 |
| ndc | 33342-045-10 |
| ndc | 33342-045-12 |
| ndc | 33342-045-07 |
| ndc | 33342-045-44 |
| ndc | 33342-046-10 |
| ndc | 33342-046-12 |
| ndc | 33342-046-07 |
| ndc | 33342-046-44 |
| code_info | Lot # BLI2002A, exp. date 11/2022 BLI2004A, exp. date 11/2022 BLI2104B, exp. date 05/2023 |
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-0833-2022%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.