drugs Class III Updated 2013-12-25

Fresenius Kabi USA, LLC recalls FOLIC ACID INJECTION, USP; 5 mg/mL ; For IM, IV or SC Use; 1

Recalled 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

Hazard / Issue

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

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Lot 6104649, Exp. 02/14; 6104789, Exp. 03/14; 6105069, Exp. 04/14
View official government recall

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