PEMBROLIZUMAB 200 MG / NS IVPB recalled over sterility concerns
- Recall date
- June 12, 2019
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Official notice title
- Infusion Options, Inc. recalls PEMBROLIZUMAB 200 MG / 100 ML NS IVPB, Rx Only, Infusion Options, Inc. 5924 13the Ave, Brooklyn, NY 11219-4934, 718-283…
- Recall number
- D-1801-2019
- FDA classification
- Class II
- Brand / firm
- Infusion Options, Inc.
- Sold / distributed
- NY only
Why it was recalled
Lack of Assurance of Sterility
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
PEMBROLIZUMAB 200 MG / 100 ML NS IVPB, Rx Only, Infusion Options, Inc. 5924 13the Ave, Brooklyn, NY 11219-4934, 718-283-7233
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