Recalls / Class III
Class IIID-0093-2024
Product
Mycophenolate Mofetil for Oral Suspension, USP, 200 mg/mL, Rx Only, bottle, Manufactured for: VistaPharm, Inc., Largo, FL 33771, USA, NDC#66689-307-08.
- Brand name
- Mycophenolate Mofetil
- Generic name
- Mycophenolate Mofetil
- Active ingredient
- Mycophenolate Mofetil
- Route
- Oral
- NDC
- 66689-307
- FDA application
- ANDA210370
- Affected lot / code info
- Lot #: M23400A, M23401A, M23402A, Exp Date. 04/30/2025; M23591A, M23592A, Exp Date. 06/30/2025.
Why it was recalled
Defective Container: The adaptor does not fit into the neck of the bottle after reconstitution with water.
Recalling firm
- Firm
- VistaPharm LLC
- Manufacturer
- VistaPharm, LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 7265 Ulmerton Rd, Largo, Florida 33771-4809
Distribution
- Quantity
- 11,633 bottles
- Distribution pattern
- Nationwide and Saudi Arabia
Timeline
- Recall initiated
- 2023-10-26
- FDA classified
- 2023-11-08
- Posted by FDA
- 2023-11-15
- Terminated
- 2025-03-21
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0093-2024. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.