Drug recall
Azathioprine Tablets, USP, 50 mg, Rx only, 100 Tablets, Sandoz Inc., Princeton, NJ 08540. NDC 0781-5075-01
FDA recall event 55887 · Class III · Sandoz Incorporated
Key facts
| Event ID | 55887 |
|---|---|
| Recall numbers | D-891-2010 |
| Recalling firm | Sandoz Incorporated |
| Product type | Drugs |
| Products | Azathioprine Tablets, USP, 50 mg, Rx only, 100 Tablets, Sandoz Inc., Princeton, NJ 08540. NDC 0781-5075-01 |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | CGMP Deviations; failure to fully investigate dissolution failures prior to releasing product. |
| Initiation date | Jun 7, 2010 |
| Termination date | Dec 20, 2010 |
| City | Broomfield |
| State | CO |
| Country | United States |
| FEI number | 1717759 |
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