Why it was recalled
Marketed Without an Approved NDA/ANDA: The product is an unapproved new drug.
Product description
PIRACETAM COGNITION ENHANCING AGENT Dietary Supplement PHARMACEUTICAL GRADE 800 mg 240 Capsules per bottle CTD Labs Houston, TX 77090
Lot numbers, UPCs & expiration codes
Lot #33250311 Exp. 04/13
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-194-2013
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- May 27, 2011
- FDA report date
- Mar 20, 2013
- Quantity
- 2980 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- A B Nutrition, Inc.
Original FDA data
Every field from FDA enforcement report D-194-2013, 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 #33250311 Exp. 04/13
- Postal code
- 77379
- Report date
- Mar 20, 2013
- Product type
- Drugs
- Recall number
- D-194-2013
- Classification
- Class II
- Recalling firm
- A B Nutrition, Inc.
- Product quantity
- 2980 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 COGNITION ENHANCING AGENT Dietary Supplement PHARMACEUTICAL GRADE 800 mg 240 Capsules per bottle CTD 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