Drug recall
Losartan Potassium Tablets, USP, 25 mg, Rx only, a) 30 ct. (NDC 60429-316-30) b) 90ct. (NDC 60429-316-90) c)…
FDA recall event 85401 · Class II · Golden State Medical Supply Inc.
Key facts
| Event ID | 85401 |
|---|---|
| Recall numbers | D-1238-2020 |
| Recalling firm | Golden State Medical Supply Inc. |
| Product type | Drugs |
| Products | Losartan Potassium Tablets, USP, 25 mg, Rx only, a) 30 ct. (NDC 60429-316-30) b) 90ct. (NDC 60429-316-90) c) 1,000 ct. (60429-316-10) bottles, GSMS Incorporated, Manufactured by Arrow Pharm (Malta)… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary: Firm Initiated |
| Reason for recall | CGMP Deviations: Impurity for N-nitroso-N-methyl-4-aminobutryric Acid (NBMA) detected in active ingredient (API) used to manufacture finished products. |
| Initiation date | Apr 3, 2020 |
| Report date | Apr 22, 2020 |
| Termination date | Oct 8, 2020 |
| City | Camarillo |
| State | CA |
| Country | United States |
| FEI number | 3006458969 |
At a glance
- 1–9 Products in this recall
- 10–99 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: