FentaNYL 5 mcg Citrate recalled over sterility concerns

Recall date

June 12, 2018

Source

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

Official notice title

Avella of Deer Valley, Inc. Store 38 recalls fentaNYL 5 mcg Citrate, USP 5 mcg in 0.9% Sodium Chloride, USP QS 0.5mL. (10 mcg per mL) 5 mcg in 0.5 mL. Volume: 0.5 m…

Recall number

D-0945-2018

FDA classification

Class II

Brand / firm

Avella of Deer Valley, Inc. Store 38

Sold / distributed

Nationwide in the USA

Why it was recalled

Lack of Assurance of Sterility: Potential leakage of bags.

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 5 mcg Citrate, USP 5 mcg in 0.9% Sodium Chloride, USP QS 0.5mL. (10 mcg per mL) 5 mcg in 0.5 mL. Volume: 0.5 mL. Single dose syringe. For Cook Children's Med Ctr. By: Advanced Pharma, 9265 Kirby Dr., Houston TX 77054. NDC 15082-210-72