FDA-Drug2013-07-17Class 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 Specification

Sold states
Nationwide and Puerto Rico
Affected count
80,480 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-688-2013

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