Norepinephrine Bitartrate 8 mg Added to 0.9% Sodium Chloride 250 mL (32 mcg per mL) Single-Dose B...

FDA Recall #D-1070-2017 — Class II — July 14, 2017

Recall #D-1070-2017 Date: July 14, 2017 Classification: Class II Status: Terminated

Product Description

Norepinephrine Bitartrate 8 mg Added to 0.9% Sodium Chloride 250 mL (32 mcg per mL) Single-Dose Bag, Rx Only, Cantrell Drug Company 7321 Cantrell Rd. Little Rock, AR 72207 877-666-5222, NDC 52533-217-18

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

8928 bags

Distribution

Nationwide within the US

Code Information

Lot #: 10095, BUD: 7/27/2017; 10119, BUD: 7/31/2017; 10135, BUD: 8/2/2017; 10162, BUD: 8/6/2017; 10168, BUD: 8/7/2017; 10186, BUD: 8/9/2017; 10247, BUD: 8/15/2017; 10301, BUD: 8/21/2017; 10325, BUD: 8/24/2017; 10390, BUD: 9/5/2017; 10465, BUD: 9/18/2017; 10487, BUD: 9/20/2017; 10542, BUD: 9/27/2017

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated