FDA-Device2015-02-04Class II
HEPFLUSH-10 (HEPARIN LOCK FLUSH SOLUTION, USP) 100 USP units per 10 mL (10 USP units per mL), Single Dose Vial, Rx only -- Fresenius Kabi USA, LLC -- NDC 63323-017-10, Product Code 1710
Fresenius Kabi USA, LLC
Hazard
The lot failed pH specification.
Sold states
Nationwide Distribution
Affected count
Domestic: 69,725
Manufactured in
3 Corporate Dr, N/A, Lake Zurich, IL, United States
Products
HEPFLUSH-10 (HEPARIN LOCK FLUSH SOLUTION, USP) 100 USP units per 10 mL (10 USP units per mL), Single Dose Vial, Rx only -- Fresenius Kabi USA, LLC -- NDC 63323-017-10, Product Code 1710
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1032-2015Don't want to check this manually?
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