Drug recall
Mavik¿ trandolapril tablets 4mg, 100 count bottle, Rx only, Manufactured by Halo Pharmaceutical Inc…
FDA recall event 65851 · Class III · AbbVie Inc.
Key facts
| Event ID | 65851 |
|---|---|
| Recall numbers | D-901-2013 |
| Recalling firm | AbbVie Inc. |
| Product type | Drugs |
| Products | Mavik¿ trandolapril tablets 4mg, 100 count bottle, Rx only, Manufactured by Halo Pharmaceutical Inc., Whippany, NJ for Abbott Laboratories, North Chicago, IL 60064, USA |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Labeling: Incorrect Package Insert; product packaged with outdated version of the insert |
| Initiation date | Aug 1, 2013 |
| Report date | Aug 28, 2013 |
| Termination date | Nov 7, 2013 |
| City | North Chicago |
| State | IL |
| Country | United States |
| FEI number | 1411365 |
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: