Norepinephrine Bitartrate 16 mg Added to 0.9% Sodium Chloride 250 mL (64 mcg per mL) Single-Dose ...

FDA Recall #D-1071-2017 — Class II — July 14, 2017

Recall #D-1071-2017 Date: July 14, 2017 Classification: Class II Status: Terminated

Product Description

Norepinephrine Bitartrate 16 mg Added to 0.9% Sodium Chloride 250 mL (64 mcg per mL) Single-Dose Bag, Rx Only, Cantrell Drug Company 7321 Cantrell Rd. Little Rock, AR 72207 877-666-5222, NDC 52533-288-18

Reason for Recall

Lack of Sterility Assurance.

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

1718 bags

Distribution

Nationwide within the US

Code Information

Lot 3:: 10374, BUD: 8/4/2017; 10429, BUD: 8/13/2017; 10532, BUD: 8/27/2017

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated