Why it was recalled
Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.
Product description
CEREBROLYSIN, 107.5 MG/ML, 10 ML vial, The Guyer Institute of Molecular Medicine, Indianapolis, IN
Lot numbers, UPCs & expiration codes
Lot #1110202004 Exp 12/10/2020
Where it was sold
CA, CO, FL, IN, KY, OH, TX
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-0139-2021
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Nov 30, 2020
- FDA report date
- Dec 23, 2020
- Quantity
- 1 vial
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Advanced Nutriceuticals, LLC
Original FDA data
Every field from FDA enforcement report D-0139-2021, exactly as published.
Show all FDA fields
- City
- Indianapolis
- State
- IN
- Status
- Ongoing
- Country
- United States
- Event ID
- 86799
- Address
- 836 E 86th St
- Code information
- Lot #1110202004 Exp 12/10/2020
- Postal code
- 46240-1806
- Report date
- Dec 23, 2020
- Product type
- Drugs
- Recall number
- D-0139-2021
- Classification
- Class II
- Recalling firm
- Advanced Nutriceuticals, LLC
- Product quantity
- 1 vial
- Reason for recall
- Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- CEREBROLYSIN, 107.5 MG/ML, 10 ML vial, The Guyer Institute of Molecular Medicine, Indianapolis, IN
- Distribution pattern
- CA, CO, FL, IN, KY, OH, TX
- Recall initiation date
- Nov 30, 2020
- Initial firm notification
- Letter
- Center classification date
- Dec 11, 2020