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 |
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