Drug recall
Valsartan/HCTZ 160/12.5 mg Tablets, 90-count jar, Rx Only, Packaged by NuCare Pharmaceuticals, Inc., Orange…
FDA recall event 80701 · Class II · NuCare Pharmaceuticals Inc
Key facts
| Event ID | 80701 |
|---|---|
| Recall numbers | D-1037-2018, D-1038-2018, D-1039-2018 |
| Recalling firm | NuCare Pharmaceuticals Inc |
| Product type | Drugs |
| Products | Valsartan/HCTZ 160/12.5 mg Tablets, 90-count jar, Rx Only, Packaged by NuCare Pharmaceuticals, Inc., Orange, CA 92867, NDC 68071-4311-9, Valsartan/HCTZ 160/25mg Tablets, 30-count jar, Rx Only, Packaged by NuCare Pharmaceuticals, Inc., Orange, CA 92867,, Valsartan/HCTZ 320/25mg Tablets, 30-count jar, Rx Only, Packaged by NuCare Pharmaceuticals, Inc., Orange, CA 92867, NDC 68071-4183-3 |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. |
| Initiation date | Jul 30, 2018 |
| Report date | Aug 15, 2018 |
| Termination date | Apr 22, 2021 |
| City | Orange |
| State | CA |
| Country | United States |
| FEI number | 3003294404 |
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: