D-0302-2015 Class III Terminated
FDA drug recall D-0302-2015 was initiated by Eisai Inc on December 5, 2014 and is designated Class III. 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. The recall status is terminated (terminated May 21, 2015). Affected quantity: 121,680 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- December 24, 2014
- Initiation Date
- December 5, 2014
- Termination Date
- May 21, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 121,680 bottles
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.
Distribution Pattern
Nationwide.
Code Information
Lot #13297008, Exp. 11/15;13307008, Exp. 11/15;13367008, Exp.12/15.