Drug recall D-379-2014

Class III Terminated reported Dec 25, 2013

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

Reason for recall

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

Lots and codes

Lot 6104649, Exp. 02/14; 6104789, Exp. 03/14; 6105069, Exp. 04/14

Recall details

Recalling firm
Fresenius Kabi USA, LLC, Lake Zurich, IL
Quantity
215,340 vials
Distribution
Nationwide, Puerto Rico, Canada, New Zealand
Type
Voluntary: Firm initiated
Recall initiated
December 6, 2013
Terminated
May 21, 2015

Related products