Prescription Mycophenolate Mofetil Oral Suspension Recalled for Defective Container Adaptor
VistaPharm is recalling Mycophenolate Mofetil Oral Suspension because the adaptor does not fit the bottle after reconstitution. Affected lots were distributed nationwide and to Saudi Arabia.
What this means for you
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: This FDA Class III recall involves a packaging defect (defective adaptor) with no reported deaths, illnesses, injuries, or adverse events. Class III recalls are typically low to moderate severity, and this recall meets the criteria for a packaging-only problem.
Plain-English summary
VistaPharm LLC is recalling Mycophenolate Mofetil for Oral Suspension, USP, 200 mg/mL (NDC 66689-307-08) due to a defective container. The adaptor does not fit into the bottle neck after reconstitution with water.
The recall affects approximately 11,633 bottles from lot numbers M23400A, M23401A, M23402A (expiration 04/30/2025) and M23591A, M23592A (expiration 06/30/2025). These bottles were distributed nationwide and to Saudi Arabia.
Patients who have received affected bottles should consult their healthcare provider. Healthcare facilities and pharmacies are advised to quarantine any bottles from the listed lot numbers and contact VistaPharm LLC for return or replacement instructions.
The recalled product
- Product
- MYCOPHENOLATE MOFETIL (MYCOPHENOLATE MOFETIL)
- Brand
- MYCOPHENOLATE MOFETIL
- Manufacturer
- VistaPharm LLC
- Category
- Drug — Oral Suspension
- Affected units
- 11,633
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (7)
- Lot #: M23400A
- M23401A
- M23402A
- Exp Date. 04/30/2025
- M23591A
- M23592A
- Exp Date. 06/30/2025.
Distribution
Distributed nationwide across the United States.
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