Mycophenolate Mofetil for Injection recalled over possible glass fragments
- Recall date
- April 30, 2019
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Official notice title
- Par Pharmaceutical, Inc. recalls Mycophenolate Mofetil for Injection, USP 500 mg, 4 Single Dose Vials, Rx Only, Distributed by: Par Pharmaceutical Chest…
- Recall number
- D-1293-2019
- FDA classification
- Class I
- Brand / firm
- Par Pharmaceutical, Inc.
- Sold / distributed
- nationwide
Why it was recalled
Presence of Particulate Matter; glass fragment observed in one vial of reconstituted product
Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.
What was recalled
Mycophenolate Mofetil for Injection, USP 500 mg, 4 Single Dose Vials, Rx Only, Distributed by: Par Pharmaceutical Chestnut Ridge, NY 10977 NDC 342023-172-044
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