FDA-Drug2013-09-04Class II

Ketorolac Tromethamine Inj., USP, 30 mg vial, Rx only, Hospira, Inc., Lake Forest, IL 60045 USA, NDC 0409-3795-01

Hospira, Inc.
Hazard

Lack of Assurance of Sterility: Either a loose crimp or no crimp was applied to the fliptop vials.

Sold states
Naitonwide
Affected count
345,800 vials
Manufactured in
600 N Field Dr Bldg J45, Lake Forest, IL, United States
Products
Ketorolac Tromethamine Inj., USP, 30 mg vial, Rx only, Hospira, Inc., Lake Forest, IL 60045 USA, NDC 0409-3795-01

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-926-2013

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