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U.S. Department of Health and Human Services

Enforcement Report - Week of December 26, 2013

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Product Detail

Product Description 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
Recall Number D-379-2014
Classification Class III
Code Info Lot 6104649, Exp. 02/14; 61047869, Exp. 03/14; 6105069, Exp. 04/14
Product Distributed Qty 215,340 vials
Reason For Recall Failed Impurities/Degradation specifications: out-of-specification results at the 14 & 15 month time point

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 Letter
Distribution Pattern Nationwide, Puerto Rico, Canada, New Zealand