FDAClass IIIDecember 24, 2014

Belviq¿ recall: Labeling Error

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.

Why was Belviq¿ 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.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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

Product
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.
Recalling firm
Eisai Inc
Quantity
121,680 bottles
Distribution
Nationwide.
Recall date
December 24, 2014
Classification
Class III
Status
Terminated
Agency
FDA (drug)
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