Enforcement Report - Week of March 13, 2013
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Product Detail
| Product Description | HEXTEND 6% Hetastarch in Lactated Electrolyte Injection, 500 mL, Rx only , MANUFACTURED AND DISTRIBUTED BY HOSPIRA, INC., LAKE FOREST, IL 60045, NDC 0409-1555-54 |
|---|---|
| Recall Number | D-184-2013 |
| Classification | Class II |
| Code Info | Lot # 10-199-JT Exp. 10/13 |
| Product Distributed Qty | 11,412 bags |
| Reason For Recall | Lack of Assurance of Sterility: There is the potential for the solution to leak from the seal of the fill tube to the bag. |
Event Detail
| Event Id | 63522 |
|---|---|
| Product Type | Drugs |
| Status | Ongoing |
| Recalling Firm | Hospira Inc. |
| City | Lake Forest |
| State | IL | Country | US |
| Voluntary / Mandated | Voluntary: Firm Initiated |
| Recall Initiation Date | 2012-10-22 |
| Initial Firm Notification of Consignee or Public | Letter |
| Distribution Pattern | Nationwide |
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