May 2017 FDA Recall Drug by Global Marketing Enterprises, Inc.
D-1096-2017 - Marketed without an Approved NDA/ANDA

This Class II drug recall was voluntarily initiated by Global Marketing Enterprises, Inc. on May 22, 2017 for the product Drug. The FDA reported the reason for recall as marketed without an approved nda/anda. The product was distributed in KY, VA, MI and the recall is currently terminated.

Recall Number: D-1096-2017

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.
Initiated
05-22-2017
Reported
08-23-2017
Quantity
52.5 kg

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
77357
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Global Marketing Enterprises, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
KY, VA, MI
Termination Date About Termination Date
Date that FDA officially terminated the recall.
08-25-2022
Product Description About Product Description
Full technical description of the product.
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

Batch or Lot Expiration Information

Batch# 15121931, 15121939, Exp 12/19