The Recall Desk

FDA (Drugs) recall action 73301

Genzyme Corporation recalled 2 products on 2016-03-09

The FDA (Drugs) publishes a recall like this one as 2 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 2 pages.

Products
2
Announced
2016-03-09
Critical
0
Units
31,691

Why these products were recalled

Presence of Particulate Matter: Glass particles found in the product after reconstitution.

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

1–2 of 2

  • SevereFDA (Drugs)··2016-03-09

    Genzyme Recalls Thyrogen Injection Vials Due to Glass Particulate Matter

    Genzyme Corporation is recalling 27,022 vials of Thyrogen (thyrotropin alfa) because glass particles were found in the product after reconstitution.

    Product
    Thyrogen (thyrotropin alfa for injection), 0.9 mg/mL after reconstitution, For intramuscular injection only, Rx Only, Four vials per Carton, Carton contains 2 vials of Thyrogen and 2 vials of diluent, Storage: store at 2-8 C, Genzyme Corporation, Cambridge, MA 02142, NDC 58468-1
    Category
    Distribution
    1 state