FOLIC ACID INJECTION, USP; 5 mg/mL ; For IM, IV or SC Use; 10 mL; Multiple Dose Vial; Rx only; AP...
FDA Recall #D-379-2014 — Class III — December 6, 2013
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
Reason for Recall
Failed Impurities/Degradation specifications: out-of-specification results 14 & 15 month time point
Recalling Firm
Fresenius Kabi USA, LLC — Lake Zurich, IL
Classification
Class III — Not likely to cause adverse health consequences.
Product Type
Drugs
Product Quantity
215,340 vials
Distribution
Nationwide, Puerto Rico, Canada, New Zealand
Code Information
Lot 6104649, Exp. 02/14; 6104789, Exp. 03/14; 6105069, Exp. 04/14
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated