D-1096-2017 Class II Terminated
FDA drug recall D-1096-2017 was initiated by Global Marketing Enterprises, Inc. on May 22, 2017 and is designated Class II. 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 … The recall status is terminated (terminated August 25, 2022). Affected quantity: 52.5 kg.
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