FDA-Drug2013-12-25Class III
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
Fresenius Kabi USA, LLC
Hazard
Failed Impurities/Degradation specifications: out-of-specification results 14 & 15 month time point
Sold states
Nationwide, Puerto Rico, Canada, New Zealand
Affected count
215,340 vials
Manufactured in
3 Corporate Dr, N/A, Lake Zurich, IL, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-379-2014Don't want to check this manually?
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