FDA-Device2012-06-27Class II
HEPARIN LOCK FLUSH SOLUTION, USP, 100 USP Units/mL, 1 mL Multiple Dose Vial, plastic vial, vial size 3 mL, NDC 63323-545-01, Product Code 504501; and HEPARIN LOCK FLUSH SOLUTION, USP, 100 USP Units/mL, 5 mL Multiple Dose Vial, 500 USP Units/5 mL, plastic vial, vial size 6 mL, NDC 63323-545-05, Product Code 504505; Rx only To maintain patency of an indwelling venipuncture device designed for intermittent injection or infusion therapy or blood sampling.
App Pharmaceuticals Llc
Hazard
CGMP Deviations: Incomplete documentation associated with test results.
Sold states
Nationwide Distribution and Puerto Rico
Affected count
Product Code 504501 (1 mL): 454,275 vials; Product Code 504505 (5 mL): 119,325 vials
Manufactured in
1501 E Woodfield Rd, Suite 300 East, Schaumburg, IL, United States
Products
HEPARIN LOCK FLUSH SOLUTION, USP, 100 USP Units/mL, 1 mL Multiple Dose Vial, plastic vial, vial size 3 mL, NDC 63323-545-01, Product Code 504501; and HEPARIN LOCK FLUSH SOLUTION, USP, 100 USP Units/mL, 5 mL Multiple Dose Vial, 500 USP Units/5 mL, plastic vial, vial size 6 mL, NDC 63323-545-05, Product Code 504505; Rx only To maintain patency of an indwelling venipuncture device designed for intermittent injection or infusion therapy or blood sampling.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1825-2012Don't want to check this manually?
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