FDA Recall D-1327-2014

HUMAN SCIENCE FOUNDATION · Gardena, CA

Class I — life-threatening Terminated 248 days on record

Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.

Product

PRO ArthMax Dietary Supplement tablets, 750 mg, 120 count bottles, Distributed by Human Science Foundation, Los Angeles, CA

Lot / code: 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

Quantity: 24,268 bottles

Reason for recall

Marketed without an Approved NDA/ANDA; FDA analysis found the product to contain Chlorzoxazone, Nefopam, Diclofenac, Ibuprofen, Naproxen, and Indomethacin

Recall record

Recall number: D-1327-2014
Classification: Class I
Status: Terminated
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Press Release
Distribution: Nationwide
Recall initiated: 2014-01-13
Classified by FDA Center: 2014-05-19
FDA published: 2014-05-28
Terminated: 2014-09-18
Recalling firm: HUMAN SCIENCE FOUNDATION
Firm location: Gardena, CA

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