Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

HEPARIN LOCK FLUSH SOLUTION Recalled by App Pharmaceuticals Llc Due to CGMP Deviations: Incomplete documentation associated with test results.

Date: May 20, 2010
Company: App Pharmaceuticals Llc
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact App Pharmaceuticals Llc directly.

Affected Products

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.

Quantity: 133,150 vials

Why Was This Recalled?

CGMP Deviations: Incomplete documentation associated with test results.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About App Pharmaceuticals Llc

App Pharmaceuticals Llc has 2 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report