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

Firm: Fresenius Kabi USA, LLC

Classification: Class III

Status: Terminated

Report Date: 20131225

Initiation Date: 20131206

Termination Date: 20150521

Failed Impurities/Degradation specifications: out-of-specification results 14 & 15 month time point

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