Diltiazem HCl 125 mg in 5% Dextrose 125 mL Single-Dose- Bag, Rx Only, Cantrell Drug Company 7321...

FDA Recall #D-1073-2017 — Class II — July 14, 2017

Recall #D-1073-2017 Date: July 14, 2017 Classification: Class II Status: Terminated

Product Description

Diltiazem HCl 125 mg in 5% Dextrose 125 mL Single-Dose- Bag, Rx Only, Cantrell Drug Company 7321 Cantrell Rd. Little Rock, AR 72207 877-666-5222; NDC 52533-103-13

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

2761 bags

Distribution

Nationwide within the US

Code Information

Lot #: 10084, BUD: 7/25/2017; 10137, BUD: 8/2/2017; 10252, BUD: 8/15/2017; 10271, BUD: 8/17/2017; 10350, BUD: 8/30/2017; 10491, BUD: 9/21/2017

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated