Class II — Potential Health Hazard

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

HEPFLUSH-10 (HEPARIN LOCK FLUSH SOLUTION Recalled by Fresenius Kabi USA, LLC Due to The lot failed pH specification.

Date: December 19, 2014
Company: Fresenius Kabi USA, 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 Fresenius Kabi USA, LLC directly.

Affected Products

HEPFLUSH-10 (HEPARIN LOCK FLUSH SOLUTION, USP) 100 USP units per 10 mL (10 USP units per mL), Single Dose Vial, Rx only -- Fresenius Kabi USA, LLC -- NDC 63323-017-10, Product Code 1710

Quantity: Domestic: 69,725

Why Was This Recalled?

The lot failed pH specification.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Fresenius Kabi USA, LLC

Fresenius Kabi USA, LLC has 67 total recalls tracked by RecallDetector.

Related Recalls

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