FDA Drug recall D-0836-2022
Losartan Potassium & Hydrochlorothiazide Tablets, USP, 100 mg/25 mg, a) 30-count bottles (NDC# 33342-052-07), b) 90-count bottles (NDC # 33…
- FDA Drug
- Class II
- terminated
- Published 2022-05-11
On 2022-05-11 the FDA classified a Class II recall of Losartan Potassium & Hydrochlorothiazide Tablets, USP, 100 mg/25 mg, a) 30-count bottles (NDC# 33342-052-07), b) 90-count bottles (NDC # 33… 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-0836-2022 |
| 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 & Hydrochlorothiazide Tablets, USP, 100 mg/25 mg, a) 30-count bottles (NDC# 33342-052-07), b) 90-count bottles (NDC # 33342-052-10) c) 1000-count bottles (NDC # 33342-052-44), Rx Only, MFR: Macleods Pharma USA, Inc. Plainsboro, NJ 08536
Reason
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
Identifiers
| ndc | 33342-050-07 |
|---|---|
| ndc | 33342-050-10 |
| ndc | 33342-050-44 |
| ndc | 33342-050-12 |
| ndc | 33342-051-07 |
| ndc | 33342-051-10 |
| ndc | 33342-051-44 |
| ndc | 33342-051-12 |
| ndc | 33342-052-07 |
| ndc | 33342-052-10 |
| ndc | 33342-052-44 |
| ndc | 33342-052-12 |
| code_info | Lot # BLM2106B, exp. date 05/2023 BLM2101A, exp. date 01/2025 BLM2102A, exp. date 02/2023 BLM2106A, exp. date 05/2…Lot # BLM2106B, exp. date 05/2023 BLM2101A, exp. date 01/2025 BLM2102A, exp. date 02/2023 BLM2106A, exp. date 05/2023 BLM2103B, exp. date 02/2023 BLM2104A, exp. date 05/2023 BLM2110A, exp. date 06/2023 |
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-0836-2022%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.