Par Pharmaceutical Recalls Mycophenolate Mofetil Injection Due to Glass Fragment
Par Pharmaceutical is recalling Mycophenolate Mofetil for Injection due to the presence of particulate matter and a glass fragment in one vial.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classification is FDA Class I, which mandates a minimum severity score of 4 according to the rubric.
Plain-English summary
Par Pharmaceutical, Inc. is recalling 4,506 packs of Mycophenolate Mofetil for Injection, USP 500 mg, 4 Single Dose Vials. The recall was initiated because particulate matter, specifically a glass fragment, was observed in one vial of the reconstituted product.
The affected product is identified by lot code AD812 with an expiration date of 9/2020. The product was distributed nationwide. Mycophenolate Mofetil is a prescription drug administered intravenously.
Healthcare providers and patients should stop using the affected product and contact Par Pharmaceutical for further instructions or a replacement.
The recalled product
- Product
- MYCOPHENOLATE MOFETIL (MYCOPHENOLATE MOFETIL)
- Brand
- MYCOPHENOLATE MOFETIL
- Manufacturer
- Par Pharmaceutical, Inc.
- Category
- Drug — Prescription Injection
- Affected units
- 4,506
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)
- AD812
- exp 9/2020
UPCs (1)
- 342023172044
Distribution
Distributed nationwide across the United States.
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