Drug product
PRO ArthMax Dietary Supplement tablets, 750 mg, 120 count bottles, Distributed by Human Science Foundation, Los Angeles, CA
D-1327-2014
Product summary
- Event
- Event 67265
- Status
- Terminated
- Classification
- Class I
- Quantity
- 24,268 bottles
- Official record key
drug-enforcement:D-1327-2014
Official wording
Reason: Marketed without an Approved NDA/ANDA; FDA analysis found the product to contain Chlorzoxazone, Nefopam, Diclofenac, Ibuprofen, Naproxen, and Indomethacin
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
Distribution pattern: Nationwide
Derived failure modes
-
Unknown
Marketed without an Approved NDA/ANDA; FDA analysis found the product to contain Chlorzoxazone, Nefopam, Diclofenac, Ibuprofen, Naproxen, and Indomethacin