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U.S. Department of Health and Human Services

Enforcement Report - Week of September 4, 2013

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Product Detail

Product Description Ketorolac Tromethamine Inj., USP, 30 mg vial, Rx only, Hospira, Inc., Lake Forest, IL 60045 USA, NDC 0409-3795-01
Recall Number D-926-2013
Classification Class II
Code Info Lot 25048DK Exp. 01/15
Product Distributed Qty 345,800 vials
Reason For Recall Lack of Assurance of Sterility: Either a loose crimp or no crimp was applied to the fliptop vials.

Event Detail

Event Id 66050
Product Type Drugs
Status Ongoing
Recalling Firm Hospira, Inc.
City Lake Forest
State IL
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-08-12
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Naitonwide