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Recall Observatory FDA recall evidence

Drug 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.

D-0302-2015

December 05, 2014

Class III

Product summary

Firm
Eisai Inc
Event
Event 69959
Status
Terminated
Classification
Class III
Quantity
121,680 bottles
Official record key
drug-enforcement:D-0302-2015

Official wording

Reason: Labeling:Missing Label: Bottles may not have a product label, or have a label with missing or illegible lot number and/or expiry date.

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

Distribution pattern: Nationwide.

Derived failure modes

  • Labeling or packaging

    reason.labeling_packaging · v1.0.0

    Labeling:Missing