BELVIQ¿ (Lorcaserin HCl) Tablets, 10 mg, 60-count bottle, Rx only, Manufactured by: Arena Pharmac...

FDA Recall #D-0302-2015 — Class III — December 5, 2014

Recall #D-0302-2015 Date: December 5, 2014 Classification: Class III Status: Terminated

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.

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.

Recalling Firm

Eisai Inc — Research Triangle Park, NC

Classification

Class III — Not likely to cause adverse health consequences.

Product Type

Drugs

Product Quantity

121,680 bottles

Distribution

Nationwide.

Code Information

Lot #13297008, Exp. 11/15;13307008, Exp. 11/15;13367008, Exp.12/15.

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated