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.
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
Lot numbers, UPCs & expiration codes
Batch # 15121931, 15121939, Exp 12/19
Where it was sold
KY, VA, MI
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-1096-2017
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- May 22, 2017
- FDA report date
- Aug 23, 2017
- Quantity
- 52.5 kg
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Global Marketing Enterprises, Inc.
Original FDA data
Every field from FDA enforcement report D-1096-2017, exactly as published.
Show all FDA fields
- City
- Chicago
- State
- IL
- Status
- Terminated
- Country
- United States
- Event ID
- 77357
- Address
- 1801 S Canal St
- Code information
- Batch # 15121931, 15121939, Exp 12/19
- Postal code
- 60616-1522
- Report date
- Aug 23, 2017
- Product type
- Drugs
- Recall number
- D-1096-2017
- Classification
- Class II
- Recalling firm
- Global Marketing Enterprises, Inc.
- Product quantity
- 52.5 kg
- Termination date
- Aug 25, 2022
- 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.
- Voluntary / mandated
- Voluntary: Firm initiated
- 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
- Distribution pattern
- KY, VA, MI
- Recall initiation date
- May 22, 2017
- Initial firm notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Center classification date
- Aug 17, 2017