Why it was recalled
Labeling:Missing Label: Bottles may not have a product label, or have a label with missing or illegible lot number and/or expiry date.
Product description
BELVIQ¿ (Lorcaserin HCl) Tablets, 10 mg, 60-count bottle, Rx only, Manufactured by: Arena Pharmaceuticals, GmbH, Zofingen, Switzerland, Distributed by: Elsai Inc., Woodcliff, NJ 07677 NDC 62856-52960.
Lot numbers, UPCs & expiration codes
Lot #13297008, Exp. 11/15;13307008, Exp. 11/15;13367008, Exp.12/15.
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-0302-2015
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Dec 5, 2014
- FDA report date
- Dec 24, 2014
- Quantity
- 121,680 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Eisai Inc
Original FDA data
Every field from FDA enforcement report D-0302-2015, exactly as published.
Show all FDA fields
- City
- Research Triangle Park
- State
- NC
- Status
- Terminated
- Country
- United States
- Event ID
- 69959
- Address
- 900 Davis Drive
- Code information
- Lot #13297008, Exp. 11/15;13307008, Exp. 11/15;13367008, Exp.12/15.
- Postal code
- 27709
- Report date
- Dec 24, 2014
- Product type
- Drugs
- Recall number
- D-0302-2015
- Classification
- Class III
- Recalling firm
- Eisai Inc
- Product quantity
- 121,680 bottles
- Termination date
- May 21, 2015
- Reason for recall
- Labeling:Missing Label: Bottles may not have a product label, or have a label with missing or illegible lot number and/or expiry date.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- BELVIQ¿ (Lorcaserin HCl) Tablets, 10 mg, 60-count bottle, Rx only, Manufactured by: Arena Pharmaceuticals, GmbH, Zofingen, Switzerland, Distributed by: Elsai Inc., Woodcliff, NJ 07677 NDC 62856-52960.
- Distribution pattern
- Nationwide.
- Recall initiation date
- Dec 5, 2014
- Initial firm notification
- Letter
- Center classification date
- Dec 16, 2014