Why it was recalled
Defective Container: The adaptor does not fit into the neck of the bottle after reconstitution with water.
Product description
Mycophenolate Mofetil for Oral Suspension, USP, 200 mg/mL, Rx Only, bottle, Manufactured for: VistaPharm, Inc., Largo, FL 33771, USA, NDC#66689-307-08.
Lot numbers, UPCs & expiration codes
Lot #: M23400A, M23401A, M23402A, Exp Date. 04/30/2025; M23591A, M23592A, Exp Date. 06/30/2025.
Where it was sold
Nationwide and Saudi Arabia
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-0093-2024
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Oct 26, 2023
- FDA report date
- Nov 15, 2023
- Quantity
- 11,633 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- VistaPharm LLC
Original FDA data
Every field from FDA enforcement report D-0093-2024, exactly as published.
Show all FDA fields
- City
- Largo
- State
- FL
- Status
- Terminated
- Country
- United States
- Event ID
- 93322
- Address
- 7265 Ulmerton Rd
- Code information
- Lot #: M23400A, M23401A, M23402A, Exp Date. 04/30/2025; M23591A, M23592A, Exp Date. 06/30/2025.
- Postal code
- 33771-4809
- Report date
- Nov 15, 2023
- Product type
- Drugs
- Recall number
- D-0093-2024
- Classification
- Class III
- Recalling firm
- VistaPharm LLC
- Product quantity
- 11,633 bottles
- Termination date
- Mar 21, 2025
- Reason for recall
- Defective Container: The adaptor does not fit into the neck of the bottle after reconstitution with water.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Mycophenolate Mofetil for Oral Suspension, USP, 200 mg/mL, Rx Only, bottle, Manufactured for: VistaPharm, Inc., Largo, FL 33771, USA, NDC#66689-307-08.
- Distribution pattern
- Nationwide and Saudi Arabia
- Recall initiation date
- Oct 26, 2023
- Initial firm notification
- Letter
- Center classification date
- Nov 8, 2023