Why it was recalled
Marketed Without an Approved NDA/ANDA: The product is an unapproved new drug.
Product description
PIRACETAM POWDER COGNITION ENHANCING AGENT Dietary Supplement CTD 500 grams PHARMACEUTICAL GRADECTD Labs Houston, TX 77090
Lot numbers, UPCs & expiration codes
Lot # 33280311 Exp. 03/13
Where it was sold
In retail store located in TX and internet sales nationwide.
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-195-2013
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- May 27, 2011
- FDA report date
- Mar 20, 2013
- Quantity
- 509 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- A B Nutrition, Inc.
Original FDA data
Every field from FDA enforcement report D-195-2013, exactly as published.
Show all FDA fields
- City
- Spring
- State
- TX
- Status
- Terminated
- Country
- United States
- Event ID
- 59001
- Address
- 5407 Louetta, Suite E
- Code information
- Lot # 33280311 Exp. 03/13
- Postal code
- 77379
- Report date
- Mar 20, 2013
- Product type
- Drugs
- Recall number
- D-195-2013
- Classification
- Class II
- Recalling firm
- A B Nutrition, Inc.
- Product quantity
- 509 bottles
- Termination date
- Jul 29, 2013
- Reason for recall
- Marketed Without an Approved NDA/ANDA: The product is an unapproved new drug.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- PIRACETAM POWDER COGNITION ENHANCING AGENT Dietary Supplement CTD 500 grams PHARMACEUTICAL GRADECTD Labs Houston, TX 77090
- Distribution pattern
- In retail store located in TX and internet sales nationwide.
- Recall initiation date
- May 27, 2011
- Initial firm notification
- Center classification date
- Mar 8, 2013