Drug recall
Losartan Potassium Tablets, USP. 50 mg. NDC# 0904-6390-61. Rx only. 100 count Unit Dose Cartons. Manufactured…
FDA recall event 83208 · Class II · MAJOR PHARMACEUTICALS
Key facts
| Event ID | 83208 |
|---|---|
| Recall numbers | D-1466-2019 |
| Recalling firm | MAJOR PHARMACEUTICALS |
| Product type | Drugs |
| Products | Losartan Potassium Tablets, USP. 50 mg. NDC# 0904-6390-61. Rx only. 100 count Unit Dose Cartons. Manufactured by Major Pharmaceuticals 17177 N. Laurel Park Drive Suite 233, Livonia, MI 48152. |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level at the manufacturer |
| Initiation date | Jan 10, 2019 |
| Report date | Jul 17, 2019 |
| Termination date | Feb 19, 2023 |
| City | Livonia |
| State | MI |
| Country | United States |
| FEI number | 3013756739 |
At a glance
- 1–9 Products in this recall
- None FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: