D-1096-2017 Class II Terminated

Recalled by Global Marketing Enterprises, Inc. — Chicago, IL

Recall Details

Product Type
Drugs
Report Date
August 23, 2017
Initiation Date
May 22, 2017
Termination Date
August 25, 2022
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
52.5 kg

Product Description

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

Reason for Recall

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.

Distribution Pattern

KY, VA, MI

Code Information

Batch # 15121931, 15121939, Exp 12/19