Why it was recalled
Failed Tablet/Capsule Specifications: Potential tablet defect of broken tablets and/or equatorial splitting of the bilayer tablets into the two drug components.
Product description
CONTRAVE (naltrexone HCl and bupropion HCl )extended-release tablets, 8 mg/ 90 mg, 120-count bottle, Rx only, Manufactured for Orexigen Therapeutics, Inc., La Jolia, CA 92037, Distributed by Takeda Pharmaceuticals America, Inc., Deerfield, IL 60015, NDC 64764-890-99.
Lot numbers, UPCs & expiration codes
Lot # B21642; Exp. 03/17
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-1206-2015
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- May 21, 2015
- FDA report date
- Jul 8, 2015
- Quantity
- 3,619 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Takeda Pharmaceuticals North America, Inc.
Original FDA data
Every field from FDA enforcement report D-1206-2015, exactly as published.
Show all FDA fields
- City
- Deerfield
- State
- IL
- Status
- Terminated
- Country
- United States
- Event ID
- 71516
- Address
- One Takeda Parkway
- Address (line 2)
- Attn Supply Chain/Transportation
- Code information
- Lot # B21642; Exp. 03/17
- Postal code
- 60015
- Report date
- Jul 8, 2015
- Product type
- Drugs
- Recall number
- D-1206-2015
- Classification
- Class II
- Recalling firm
- Takeda Pharmaceuticals North America, Inc.
- Product quantity
- 3,619 bottles
- Termination date
- Feb 20, 2018
- Reason for recall
- Failed Tablet/Capsule Specifications: Potential tablet defect of broken tablets and/or equatorial splitting of the bilayer tablets into the two drug components.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- CONTRAVE (naltrexone HCl and bupropion HCl )extended-release tablets, 8 mg/ 90 mg, 120-count bottle, Rx only, Manufactured for Orexigen Therapeutics, Inc., La Jolia, CA 92037, Distributed by Takeda Pharmaceuticals America, Inc., Deerfield, IL 60015, NDC 64764-890-99.
- Distribution pattern
- Nationwide
- Recall initiation date
- May 21, 2015
- Initial firm notification
- Letter
- Center classification date
- Jul 2, 2015