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U.S. Department of Health and Human Services

Enforcement Report - Week of December 26, 2013

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Event Detail

Event ID 67054
Product Type Drugs
Status Ongoing
Recalling Firm Fresenius Kabi USA, LLC
City Lake Zurich
State IL
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-12-06
Initial Firm Notification of
Consignee or Public
Distribution Pattern Nationwide, Puerto Rico, Canada, New Zealand

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
FOLIC ACID INJECTION, USP; 5 mg/mL ; For IM, IV or SC Use; 10 mL; Multiple Dose Vial; Rx only; APP Pharmaceuticals, LLC; Schaumburg, IL 60173 NDC 63323-184-11 Lot 6104649, Exp. 02/14; 61047869, Exp. 03/14; 6105069, Exp. 04/14 Class III Failed Impurities/Degradation specifications: out-of-specification results at the 14 & 15 month time point 215,340 vials D-379-2014