Fentanyl Citrate 2 recalled over sterility concerns

Recall date

November 18, 2016

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Cantrell Drug Company recalls Fentanyl Citrate 2,500 mcg in 0.9% Sodium Chloride (10 mcg/mL) 250 mL* Bag, Single-Dose Bag, Rx Only, Cantrell Drug Com…

Recall number

D-0189-2017

FDA classification

Class II

Brand / firm

Cantrell Drug Company

Sold / distributed

Nationwide

Why it was recalled

Lack of Assurance of Sterility - the firm is recalling select sterile drug products.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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