Drug recall
Diovan HCT(R) valsartan and hydrochlorothiazide, USP, 320 mg/12.5 mg 90 tablets, NDC 0078-0471-34, Rx only…
FDA recall event 56714 · Class II · Novartis Pharmaceuticals Corp.
Key facts
| Event ID | 56714 |
|---|---|
| Recall numbers | D-893-2010 |
| Recalling firm | Novartis Pharmaceuticals Corp. |
| Product type | Drugs |
| Products | Diovan HCT(R) valsartan and hydrochlorothiazide, USP, 320 mg/12.5 mg 90 tablets, NDC 0078-0471-34, Rx only, Novartis label --- Manufactured by: Novartis Pharmaceuticals Corp., Suffern, NY 10901… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Labeling mix-up. The firm received complaints that bottles labeled to contain Diovan HCT 320/12.5mg tablets actually contained Diovan HCT 320/25mg. |
| Initiation date | Sep 9, 2010 |
| Termination date | Jun 29, 2012 |
| City | Suffern |
| State | NY |
| Country | United States |
| FEI number | 2416082 |
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