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App Pharmaceuticals Llc recalls HEPARIN LOCK FLUSH SOLUTION, USP, 100 USP Units/mL, 1 mL Multiple Dose Vial, plastic vial, vial size 3 mL, NDC 63323-54
Recalled June 27, 2012 · FDA recall Z-1825-2012 · App Pharmaceuticals
Hazard
CGMP Deviations: Incomplete documentation associated with test results. · FDA Class II
Units
Product Code 504501 (1 mL): 454,275 vials; Product Code 504505 (5 mL): 119,325 vials
Sold at
Nationwide Distribution and Puerto Rico
Description
CGMP Deviations: Incomplete documentation associated with test results.
Product
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.
Manufacturer(s)
App Pharmaceuticals Llc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →