Fentanyl Citrate 2,500 mcg in 0.9% Sodium Chloride (10 mcg/mL) 250 mL* Bag, Single-Dose Bag, Rx O...

FDA Recall #D-0189-2017 — Class II — November 18, 2016

Recall #D-0189-2017 Date: November 18, 2016 Classification: Class II Status: Terminated

Product Description

Fentanyl Citrate 2,500 mcg in 0.9% Sodium Chloride (10 mcg/mL) 250 mL* Bag, Single-Dose Bag, Rx Only, Cantrell Drug Company 7321 Cantrell Road Little Road, AR 72207, NDC 52533-024-61

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

2545 bags

Distribution

Nationwide

Code Information

Lot: 8990

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated