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.
The agency’s classification
FDA (Drugs): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. 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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