Mycophenolate Mofetil Injection Recalled Due to Precipitate in Vials
Mylan Pharmaceuticals is recalling one lot of Mycophenolate Mofetil for Injection, 500 mg/vial, because precipitate was found in the vials. The recall covers 5,688 vials distributed nationwide.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall of an injectable drug with a visible quality defect (precipitate), but no hospitalization reports are stated in the source. It therefore fits the risk-of-harm product where injury has not yet been reported criterion, yielding a High severity.
Plain-English summary
Mylan Pharmaceuticals Inc. is recalling Mycophenolate Mofetil for Injection USP, 500 mg/Vial, Single Dose Vial, 4 vials per carton. The affected product is Lot 3241653, Exp 4/30/2027, NDC 67457-386-00, and includes 5,688 vials distributed nationwide in the USA.
The recall was initiated because of the presence of precipitate in the vials. The U.S. Food and Drug Administration has classified this as a Class II recall, meaning use of the product may cause temporary or medically reversible adverse health consequences, with the probability of serious adverse health consequences considered remote.
Healthcare providers and patients who have the affected lot should verify the lot number and expiration date on the packaging. The affected product should not be used. Patients should contact their pharmacist or healthcare provider for guidance on obtaining a replacement or alternative product.
The recalled product
- Product
- MYCOPHENOLATE MOFETIL (MYCOPHENOLATE MOFETIL)
- Brand
- MYCOPHENOLATE MOFETIL
- Manufacturer
- MYLAN PHARMACEUTICALS INC
- Category
- Drug — Injectable / Parenteral
- Hazard
- precipitate
- particulate-matter
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 (2)
- Lot #: 3241653
- Exp 4/30/2027
Distribution
Distributed nationwide across the United States.
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