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U.S. Department of Health and Human Services

Enforcement Report - Week of January 1, 2014

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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
Recall Number V-038-2014
Classification Class III
Code Info Product Code 18411; Lots and Expiration Dates: Lot 6104649, Expires 2/2014; Lot 61047869, Expries 3/2014; Lot 6105069, Expires 4/2014
Product Distributed Qty 215,340 vials
Reason For Recall Fresenius Kabi USA, LLC is recalling three lots of Folic Acid Injection, USP 5 mg / mL, 10 mL Multiple Dose Vial due to an out-of-specification result reported for impurities at the 15 and 14 month stability test station for two lots and a third lot that remains within specification to date, however based on the root cause analysis, it is expected to exhibit the same behavior prior to expiry.

Event Detail

Event Id 67079
Product Type Veterinary
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 US: Nationwide (AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA. HI. IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY) + District of Columbia + Puerto Rico; FOREIGN: Canada, New Zealand