HEPARIN LOCK FLUSH SOLUTION, USP, 10 USP Units/mL, 1 mL Multiple Dose Vial, plastic vial, vial s...
FDA Recall #Z-1824-2012 — Class II — May 20, 2010
Product Description
HEPARIN LOCK FLUSH SOLUTION, USP, 10 USP Units/mL, 1 mL Multiple Dose Vial, plastic vial, vial size 3 mL, NDC 63323-544-01, Product Code 504401, Rx only To maintain patency of an indwelling venipuncture device designed for intermittent injection or infusion therapy or blood sampling.
Reason for Recall
CGMP Deviations: Incomplete documentation associated with test results.
Recalling Firm
App Pharmaceuticals Llc — Schaumburg, IL
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
133,150 vials
Distribution
Nationwide Distribution and Puerto Rico
Code Information
Lot 406952 (Expiration Date 02/11)
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated