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

FDA recall notice · announced December 25, 2013 · Fresenius Kabi

Class III FDA/FSIS Class III: use is not likely to cause adverse health consequences.

The 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

Notes

Distribution: Nationwide, Puerto Rico, Canada, New Zealand
Lot/code information: Lot 6104649, Exp. 02/14; 6104789, Exp. 03/14; 6105069, Exp. 04/14
Quantity: 215,340 vials
Status: Terminated
Products in this recall event:
- 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 (D-379-2014)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.