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U.S. Department of Health and Human Services

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