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U.S. Department of Health and Human Services

Enforcement Report - Week of June 27, 2012

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Product Detail

Product Description Magnesium Sulfate in Water for Injection, 40 mg/mL (0.325 mEq Mg++/mL), 2 g total, 50 mL Flexible Container, Rx only, Hospira, Inc., Lake Forest, IL 60045; NDC 0409-6729-24.
Recall Number D-1390-2012
Classification Class III
Code Info Lot #: 04510KL*, Exp 01OCT2012; *lot number may have 01 or 02 following it
Product Distributed Qty 164,568 containers
Reason For Recall Superpotent (Single Ingredient) Drug: Above specification assay results for percentage of magnesium sulfate.

Event Detail

Event Id 62053
Product Type Drugs
Status Ongoing
Recalling Firm Hospira, Inc.
City Lake Forest
State IL
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-04-05
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Nationwide