HEPARIN LOCK FLUSH SOLUTION, USP, 100 USP Units/mL, 1 mL Multiple Dose Vial, plastic vial, vial ...
FDA Recall #Z-1825-2012 — Class II — May 20, 2010
Product Description
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.
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
Product Code 504501 (1 mL): 454,275 vials; Product Code 504505 (5 mL): 119,325 vials
Distribution
Nationwide Distribution and Puerto Rico
Code Information
Product Code 504501 (1 mL): Lot 406912 (Expiration Date 01/11) and Lot 408072 (Expiration Date 09/11); Product Code 504505 (5 mL): Lot 406914 (Expiration Date 01/12)
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated