Enforcement Report - Week of March 20, 2013
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Product Detail
| Product Description | CALCIUM GLUCONATE INJECTION, USP, 10% (100 mg/mL), 10 mL, Single Dose Vial, Rx only, For Direct Slow IV or IV Additive Use Only, APP Pharmaceuticals, LLC Schaumburg, IL 60173 --- Product Code 31110, NDC 63323-311-10 |
|---|---|
| Recall Number | D-200-2013 |
| Classification | Class III |
| Code Info | Lot 6004889, Expiration Date 10/2014 |
| Product Distributed Qty | 155,900 vials domestically |
| Reason For Recall | Labeling: Missing label |
Event Detail
| Event Id | 64266 |
|---|---|
| Product Type | Drugs |
| Status | Ongoing |
| Recalling Firm | Fresenius Kabi USA LLC (FK USA) |
| City | Schaumburg |
| State | IL | Country | US |
| Voluntary / Mandated | Voluntary: Firm Initiated |
| Recall Initiation Date | 2013-02-01 |
| Initial Firm Notification of Consignee or Public | Letter |
| Distribution Pattern | Nationwide |
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