Drug 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
D-1096-2017
Product summary
- Event
- Event 77357
- Status
- Terminated
- Classification
- Class II
- Quantity
- 52.5 kg
- Official record key
drug-enforcement:D-1096-2017
Official wording
Reason: 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.
Code information: Batch # 15121931, 15121939, Exp 12/19
Distribution pattern: KY, VA, MI
Derived failure modes
-
Labeling or packaging
misbranded