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U.S. Department of Health and Human Services

Enforcement Report - Week of May 15, 2013

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Product Detail

Product Description Sodium Acetate Injection, USP, 40 mEq/20 ml (2 mEq/mL) 20 mL Single-Dose Fliptop, Rx only, HOSPIRA, INC. LAKE FOREST, IL 60045 USA, NDC 0409-7299-73
Recall Number D-316-2013
Classification Class II
Code Info Lot 23-320-DK and 23-321-DK Exp. 11/14
Product Distributed Qty 266,900 vials
Reason For Recall Lack of Assurance of Sterility: Loose crimp applied to the fliptop vial.

Event Detail

Event Id 65077
Product Type Drugs
Status Ongoing
Recalling Firm Hospira Inc.
City Lake Forest
State IL
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-02-26
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Nationwide and Puerto Rico