D-1327-2014 Class I Terminated
FDA drug recall D-1327-2014 was initiated by HUMAN SCIENCE FOUNDATION on January 13, 2014 and is designated Class I. Reason for recall: Marketed without an Approved NDA/ANDA; FDA analysis found the product to contain Chlorzoxazone, Nefopam, Diclofenac, Ibuprofen, Naproxen, and Indomethacin The recall status is terminated (terminated September 18, 2014). Affected quantity: 24,268 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- May 28, 2014
- Initiation Date
- January 13, 2014
- Termination Date
- September 18, 2014
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 24,268 bottles
Product Description
PRO ArthMax Dietary Supplement tablets, 750 mg, 120 count bottles, Distributed by Human Science Foundation, Los Angeles, CA
Reason for Recall
Marketed without an Approved NDA/ANDA; FDA analysis found the product to contain Chlorzoxazone, Nefopam, Diclofenac, Ibuprofen, Naproxen, and Indomethacin
Distribution Pattern
Nationwide
Code Information
Lot# 220113; Exp. 01/16 Lot# 800213; Exp. 03/16 Lot# U133000; Exp. 04/16 Lot# U143200; Exp. 08/16 Lot# YJK015311; Exp. 10/16