The Recall Desk

FDA (Drugs) recall action 83136

Infusion Options, Inc. recalled 76 products on 2019-08-21

The FDA (Drugs) publishes a recall like this one as 76 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 76 pages.

Products
76
Announced
2019-08-21
Critical
0
Units
—

Why these products were recalled

Lack of Assurance of Sterility

The agency’s own wording, quoted from the enforcement report.

States named across these recalls

76–76 of 76

  • SevereFDA (Drugs)··2019-08-21

    Pembrolizumab Infusion Recalled Due to Lack of Sterility Assurance

    Infusion Options, Inc. is recalling Pembrolizumab 200 mg/100 mL IV products in New York due to a lack of assurance of sterility.

    Product
    PEMBROLIZUMAB 200 MG / 100 ML NS IVPB, Rx Only, Infusion Options, Inc. 5924 13the Ave, Brooklyn, NY 11219-4934, 718-283-7233
    Category
    Distribution
    1 state