Drug & medication recalls High risk

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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