FDA Drug recall D-1460-2019
Losartan Potassium and Hydrochlorothiazide Tablets, USP 100 mg/12.5 mg 90 Tablets, USP Manufactured for: Macleods Pharma USA inc
- FDA Drug
- Class II
- terminated
- Published 2019-07-17
On 2019-07-17 the FDA classified a Class II recall of Losartan Potassium and Hydrochlorothiazide Tablets, USP 100 mg/12.5 mg 90 Tablets, USP Manufactured for: Macleods Pharma USA inc by Macleods Pharma Usa, citing CGMP Deviations: impurity for N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) detected in the active pharmaceutical ingredient (API) used to manufacture finished products.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1460-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-06-20 |
| Published | 2019-07-17 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Macleods Pharma Usa |
| Distribution | US |
Product
Losartan Potassium and Hydrochlorothiazide Tablets, USP 100 mg/12.5 mg 90 Tablets, USP Manufactured for: Macleods Pharma USA inc. Plainsboro, NJ 08536 Manufactured by: Macleods Pharmaceuticals, Ltd. Baddi, Himachal Pradesh, INDIA NDC 33342-051-10
Reason
CGMP Deviations: impurity for N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) detected in the active pharmaceutical ingredient (API) used to manufacture finished products.
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 | BLL801A Dec-19 BLL802A Dec-19 BLL803A Dec-19 |
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-1460-2019%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.