HEPFLUSH-10 (HEPARIN LOCK FLUSH SOLUTION, USP) 100 USP units per 10 mL (10 USP units per mL), Sin...
FDA Recall #Z-1032-2015 — Class II — December 19, 2014
Product Description
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
Reason for Recall
The lot failed pH specification.
Recalling Firm
Fresenius Kabi USA, LLC — Lake Zurich, IL
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
Domestic: 69,725
Distribution
Nationwide Distribution
Code Information
Lot 6005501, Exp. Date 1/2016
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated