FDA recall D-0302-2015

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.

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.

Distribution

Nationwide.

Key facts

Status

Terminated

Initiation date

2014-12-05

Report date

2014-12-24

Termination date

2015-05-21

Voluntary/Mandated

Voluntary: Firm initiated

Location

Research Triangle Park, NC, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0302-2015