Recalls / Class III
Class IIID-901-2013
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
- Affected lot / code info
- Lot 22033GY
Why it was recalled
Labeling: Incorrect Package Insert; product packaged with outdated version of the insert
Recalling firm
- Firm
- AbbVie Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 1401 Sheridan Rd, N/A, North Chicago, Illinois 60064-1803
Distribution
- Quantity
- 704 bottles
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2013-08-01
- FDA classified
- 2013-08-20
- Posted by FDA
- 2013-08-28
- Terminated
- 2013-11-07
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-901-2013. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.