PlainRecalls
FDA Drug Moderate Class II Terminated

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

Reported: September 4, 2013 Initiated: August 12, 2013 #D-926-2013

Product Description

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

Reason for Recall

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

Details

Recalling Firm
Hospira, Inc.
Units Affected
345,800 vials
Distribution
Naitonwide
Location
Lake Forest, IL

Frequently Asked Questions

What product was recalled?
Ketorolac Tromethamine Inj., USP, 30 mg vial, Rx only, Hospira, Inc., Lake Forest, IL 60045 USA, NDC 0409-3795-01. Recalled by Hospira, Inc.. Units affected: 345,800 vials.
Why was this product recalled?
Lack of Assurance of Sterility: Either a loose crimp or no crimp was applied to the fliptop vials.
Which agency issued this recall?
This recall was issued by the FDA Drug on September 4, 2013. Severity: Moderate. Recall number: D-926-2013.