Drug & medication recalls Moderate risk

Caffeine Powder recalled over labeling errors

Recall date
May 22, 2017
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Official notice title
Global Marketing Enterprises, Inc. recalls Caffeine Powder, Anhydrous, Pharmaceutical Grade, 100% Pure caffeine, 250 g (8.8 oz)., 1250 servings, Packed By: LifeLi…
Recall number
D-1096-2017
FDA classification
Class II
Brand / firm
Global Marketing Enterprises, Inc.
Sold / distributed
KY, VA, MI

Why it was recalled

Marketed without an Approved NDA/ANDA: The product consists of pure, powdered caffeine and is an unapproved drug due to stimulant claims. The product is also misbranded as it fails to bear adequate directions for its intended use.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Caffeine Powder, Anhydrous, Pharmaceutical Grade, 100% Pure caffeine, 250 g (8.8 oz)., 1250 servings, Packed By: LifeLine Nutrients Corp, 1801 S. Canal St, Chicago, IL 60616, UPC 021754905076

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