Enforcement Report - Week of March 13, 2013
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Product Detail
| Product Description | 0.9% Sodium Chloride Injection USP, 100 mL Hospira, Inc., Lake Forest, IL 60045 NDC 0409-7984-23, |
|---|---|
| Recall Number | D-183-2013 |
| Classification | Class II |
| Code Info | Lot Number 02-117-JT Exp. 02/13 |
| Product Distributed Qty | 325,056 bags |
| Reason For Recall | Lack of Assurance of Sterility: There is the potential for solution to leak from the administrative port to the fill tube seal. |
Event Detail
| Event Id | 64001 |
|---|---|
| Product Type | Drugs |
| Status | Ongoing |
| Recalling Firm | Hospira Inc. |
| City | Lake Forest |
| State | IL | Country | US |
| Voluntary / Mandated | Voluntary: Firm Initiated |
| Recall Initiation Date | 2013-01-08 |
| Initial Firm Notification of Consignee or Public | Letter |
| Distribution Pattern | Nationwide |
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