Drug recall
Azathioprine Tablets, USP, 50 mg, 100 tablet bottles, Rx only, Roxane Laboratories, Inc., Columbus, Ohio, NDC…
FDA recall event 35820 · Class I · Boehringer Ingelheim Roxane Inc
Key facts
| Event ID | 35820 |
|---|---|
| Recall numbers | D-337-6 |
| Recalling firm | Boehringer Ingelheim Roxane Inc |
| Product type | Drugs |
| Products | Azathioprine Tablets, USP, 50 mg, 100 tablet bottles, Rx only, Roxane Laboratories, Inc., Columbus, Ohio, NDC 0054-4084-25 |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Label Mixup; product labeled to contain Azathioprine, 50 mg Tablets may actually contain Methotrexate, 2.5 mg Tablets |
| Initiation date | Jul 10, 2006 |
| Termination date | Dec 1, 2008 |
| City | Columbus |
| State | OH |
| Country | United States |
| FEI number | 1510690 |
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