Heparin Sodium 5,000 USP Units Added to 0.9% Sodium Chloride 1,000 mL* Bag (5 USP units/mL), Sing...

FDA Recall #D-0193-2017 — Class II — November 18, 2016

Recall #D-0193-2017 Date: November 18, 2016 Classification: Class II Status: Terminated

Product Description

Heparin Sodium 5,000 USP Units Added to 0.9% Sodium Chloride 1,000 mL* Bag (5 USP units/mL), Single-Dose Bag.,Hospital/Office Use Only, Injection Solution For IV Use, Rx Only, Cantrell Drug Company 7321 Cantrell Road Little Rock, AR 72207, NDC 52533-097-24

Reason for Recall

Lack of Assurance of Sterility - the firm is recalling select sterile drug products.

Recalling Firm

Cantrell Drug Company — Little Rock, AR

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Drugs

Product Quantity

150 bags

Distribution

Nationwide

Code Information

Lot: 167081

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated