The Recall Desk

FDA (Drugs) recall action 71002

Hospira Inc. recalled 2 products on 2015-05-06

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
2015-05-06
Critical
0
Units
—

Why these products were recalled

Crystallization

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

States named across these recalls

1–2 of 2

  • SevereFDA (Drugs)··2015-05-06

    Hospira Recalls Ketorolac Tromethamine Injections Due to Crystallization

    Hospira is voluntarily recalling specific lots of Ketorolac Tromethamine Injections because of crystallization. The affected products were distributed nationwide, in Puerto Rico, and in Guam.

    Product
    Ketorolac Tromethamine Inj. USP, 60 mg (30 mg/mL), 2 mL Fill, Single-dose vial, Rx Only, Hospira Inc., Lake Forest, IL --- NDC 00409-3796-01 --- Also labeled under NOVAPLUS label NDC 00409-3796-49
    Category
    Distribution
    2 states
  • ModerateFDA (Drugs)··2015-05-06

    Hospira Recalls Ketorolac Tromethamine Injections Due to Crystallization

    Hospira Inc. is voluntarily recalling specific lots of Ketorolac Tromethamine Injection due to crystallization. The recall covers products distributed nationwide, in Puerto Rico, and in Guam.

    Product
    Ketorolac Tromethamine Inj. USP, 30 mg (30 mg/mL), 1 mL Fill, Single-dose vial, Rx Only, Hospira Inc., Lake Forest, IL --- NDC 00409-3795-01--- Also labeled under NOVAPLUS label NDC 00409-3795-49
    Category
    Distribution
    2 states