Drug product
Mavik¿ trandolapril tablets 4mg, 100 count bottle, Rx only, Manufactured by Halo Pharmaceutical Inc., Whippany, NJ for Abbott Laboratories, North Chicago, IL 60064, USA
D-901-2013
Product summary
- Firm
- AbbVie Inc.
- Event
- Event 65851
- Status
- Terminated
- Classification
- Class III
- Quantity
- 704 bottles
- Official record key
drug-enforcement:D-901-2013
Official wording
Reason: Labeling: Incorrect Package Insert; product packaged with outdated version of the insert
Code information: Lot 22033GY
Distribution pattern: Nationwide
Derived failure modes
-
Labeling or packaging
Labeling: Incorrect