Midazolam HCl 50 mg/50 mL in 0.9% Sodium Chloride (1 mg/mL), Single-Dose Syringe, Hospital/Office...

FDA Recall #D-0198-2017 — Class II — November 18, 2016

Recall #D-0198-2017 Date: November 18, 2016 Classification: Class II Status: Terminated

Product Description

Midazolam HCl 50 mg/50 mL in 0.9% Sodium Chloride (1 mg/mL), Single-Dose Syringe, Hospital/Office Use Only, Rx Only, Cantrell Drug Co. 7321 Cantrell Road Little Rock, AR 72207, NDC 52533-001-04

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

37 syringes

Distribution

Nationwide

Code Information

Lot: 169619

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated