Drug recall
Candesartan Cilexetil Tablets, 16 mg, a) 30 count (NDC 00781-5938-31) and b) 90 count (NDC 00781-5938-92)…
FDA recall event 73035 · Class III · Sandoz Inc
Key facts
| Event ID | 73035 |
|---|---|
| Recall numbers | D-0659-2016 |
| Recalling firm | Sandoz Inc |
| Product type | Drugs |
| Products | Candesartan Cilexetil Tablets, 16 mg, a) 30 count (NDC 00781-5938-31) and b) 90 count (NDC 00781-5938-92) bottles, Rx Only, Manufactured by Mylan Laboratories Limited Hyderabad 500 034, India for… |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Failed Impurities/Degradation Specifications; 9 month stability timepoint |
| Initiation date | Dec 31, 2015 |
| Report date | Feb 17, 2016 |
| Termination date | Apr 12, 2017 |
| City | Princeton |
| State | NJ |
| Country | United States |
| FEI number | 3011552892 |
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: