Why it was recalled
Labeling: Incorrect Package Insert; product packaged with outdated version of the insert
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
Lot numbers, UPCs & expiration codes
Lot 22033GY
Where it was sold
Nationwide
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-901-2013
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Aug 1, 2013
- FDA report date
- Aug 28, 2013
- Quantity
- 704 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- AbbVie Inc.
Original FDA data
Every field from FDA enforcement report D-901-2013, exactly as published.
Show all FDA fields
- City
- North Chicago
- State
- IL
- Status
- Terminated
- Country
- United States
- Event ID
- 65851
- Address
- 1401 Sheridan Rd
- Code information
- Lot 22033GY
- Postal code
- 60064-1803
- Report date
- Aug 28, 2013
- Product type
- Drugs
- Recall number
- D-901-2013
- Classification
- Class III
- Recalling firm
- AbbVie Inc.
- Product quantity
- 704 bottles
- Termination date
- Nov 7, 2013
- Reason for recall
- Labeling: Incorrect Package Insert; product packaged with outdated version of the insert
- Voluntary / mandated
- Voluntary: Firm initiated
- 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
- Distribution pattern
- Nationwide
- Recall initiation date
- Aug 1, 2013
- Initial firm notification
- Letter
- Center classification date
- Aug 20, 2013