PRO ArthMax Dietary Supplement Recalled for Unapproved Active Ingredients
Human Science Foundation is recalling PRO ArthMax tablets because FDA analysis found unapproved prescription drugs in the product.
The agency’s classification
FDA (Drugs): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 5/5 (Critical).
Highest-severity recall. The hazard can cause serious injury or death. Stop using the product now and follow the agency's instructions.
Our severity reasoning: The agency classification is FDA Class I, which indicates a reasonable probability that use of or exposure to the violative product will cause serious adverse health consequences or death.
Plain-English summary
Human Science Foundation is recalling PRO ArthMax Dietary Supplement tablets, 750 mg, 120 count bottles. The recall involves 24,268 bottles distributed nationwide. The product was marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA).
The FDA conducted an analysis of the product and found it contained Chlorzoxazone, Nefopam, Diclofenac, Ibuprofen, Naproxen, and Indomethacin. These are active pharmaceutical ingredients that were not declared on the product label. The presence of these unapproved drugs in a dietary supplement poses a safety risk to consumers.
Consumers who have purchased PRO ArthMax Dietary Supplement tablets should stop using the product and contact Human Science Foundation for a refund or further information. The affected lots include Lot# 220113, 800213, U133000, U143200, and YJK015311.
The recalled product
- Product
- PRO ArthMax Dietary Supplement tablets, 750 mg, 120 count bottles, Distributed by Human Science Foundation, Los Angeles, CA
- Manufacturer
- HUMAN SCIENCE FOUNDATION
- Category
- Drug — Dietary Supplement
- Affected units
- 24,268
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (6)
- 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
Distributed nationwide across the United States.
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