Fresenius Kabi USA, LLC recalls FOLIC ACID INJECTION, USP; 5 mg/mL ; For IM, IV or SC Use; 10 mL; Multiple Dose Vial; Rx only; APP Pharmaceuticals, LLC;
Recalled December 25, 2013 · FDA recall D-379-2014 · Fresenius Kabi USA
Hazard
Failed Impurities/Degradation specifications: out-of-specification results 14 & 15 month time point · FDA Class III
Units
215,340 vials
Sold at
Nationwide, Puerto Rico, Canada, New Zealand
Description
Failed Impurities/Degradation specifications: out-of-specification results 14 & 15 month time point
Product
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
Manufacturer(s)
Fresenius Kabi USA, LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →