The Recall Desk

FDA (Drugs) recall action 71004

Mylan Institutional LLC recalled 3 products on 2015-08-26

The FDA (Drugs) publishes a recall like this one as 3 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 3 pages.

Products
3
Announced
2015-08-26
Critical
1
Units
12,549

Why these products were recalled

Presence of Particulate Matter

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

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

States named across these recalls

1–3 of 3

  • SevereFDA (Drugs)··2015-08-26

    Mylan Recalls Gemcitabine for Injection Due to Particulate Matter

    Mylan Institutional LLC is recalling 10,094 vials of Gemcitabine for Injection due to the presence of particulate matter.

    Product
    Gemcitabine for Injection, USP, 1 g*/vial, Lyophilized powder in a Single-Use Vial, Rx only, Manufactured for: Mylan Institutional LLC, Rockford, IL 61103, Made in India, NDC 67457-462-01, UPC 3 67457 46201 1.
    Category
    Distribution
    1 state
  • SevereFDA (Drugs)··2015-08-26

    Mylan Recalls Gemcitabine Injection Vials Due to Particulate Matter

    Mylan Institutional LLC is recalling specific lots of Gemcitabine for Injection due to the presence of particulate matter. The affected vials were distributed nationwide and in Puerto Rico.

    Product
    Gemcitabine for Injection, USP, 200 mg*/vial, Lyophilized powder in a Single-Use Vial, Rx only, labeled as a) Manufactured for: Mylan Institutional LLC, Rockford, IL 61103, Made in India, NDC 67457-464-20, UPC 3 67457 46420 6; and b) Distributed by Pfizer Labs, Division of…
    Category
    Distribution
    1 state
  • CriticalFDA (Drugs)··2015-08-26

    Mylan Recalls Gemcitabine Injection Vials Due to Particulate Matter

    Mylan Institutional LLC is recalling 2,455 vials of Gemcitabine for Injection due to the presence of particulate matter.

    Product
    Gemcitabine for Injection, USP, 2 g*/vial, Lyophilized powder in a Single-Use Vial, Rx only, Manufactured for: Mylan Institutional LLC, Rockford, IL 61103, Made in India, NDC 67457-463-02, UPC 3 67457 46302 5.
    Category
    Distribution
    1 state