Ketorolac Tromethamine Inj recalled over temperature-control failures

Recall date

October 6, 2014

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Hospira Inc. recalls Ketorolac Tromethamine Inj., USP, 60 mg (30 mg/mL), 2 mL Single-dose Fliptop Vial, packaged in 25 Units per carton, Rx…

Recall number

D-0388-2015

FDA classification

Class II

Brand / firm

Hospira Inc.

Sold / distributed

Distribution limited to one shipment to The Harvard Drug Group, Livonia, MI for the lots of Vancomycin 500 mg, Ketorolac tromethamine 60 mg/2 mL (30 mg/mL), and Propofol 1% 200 mg/20 mL (10 mg/mL), these lots remained within the control of the distributor and were not further distributed. Distribut…

Why it was recalled

Temperature Abuse: Products experienced uncontrolled temperature excursions during transit.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Ketorolac Tromethamine Inj., USP, 60 mg (30 mg/mL), 2 mL Single-dose Fliptop Vial, packaged in 25 Units per carton, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-3796-01.