D-901-2013 Class III Terminated
FDA drug recall D-901-2013 was initiated by AbbVie Inc. on August 1, 2013 and is designated Class III. Reason for recall: Labeling: Incorrect Package Insert; product packaged with outdated version of the insert The recall status is terminated (terminated November 7, 2013). Affected quantity: 704 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- August 28, 2013
- Initiation Date
- August 1, 2013
- Termination Date
- November 7, 2013
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 704 bottles
Product Description
Mavik¿ trandolapril tablets 4mg, 100 count bottle, Rx only, Manufactured by Halo Pharmaceutical Inc., Whippany, NJ for Abbott Laboratories, North Chicago, IL 60064, USA
Reason for Recall
Labeling: Incorrect Package Insert; product packaged with outdated version of the insert
Distribution Pattern
Nationwide
Code Information
Lot 22033GY