Fresenius Kabi USA, LLC recalls HEPFLUSH-10 (HEPARIN LOCK FLUSH SOLUTION, USP) 100 USP units per 10 mL (10 USP units per mL), Single Dose Vial, Rx only…

Recall date

December 19, 2014

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1032-2015

FDA classification

Class II

Brand / firm

Fresenius Kabi USA, LLC

Sold / distributed

Nationwide Distribution

Why it was recalled

The lot failed pH specification.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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