FentaNYL in 0 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 (10 mcg per mL) in 0.95 Sodium Chloride, USP QS 1mL. Volume 1mL. Single dose Syringe. For: Hunt Regional Medic…

Recall number

D-0933-2018

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 (10 mcg per mL) in 0.95 Sodium Chloride, USP QS 1mL. Volume 1mL. Single dose Syringe. For: Hunt Regional Medical Center, By: Advanced Pharma, 9265 Kirby Dr,., Houston, TX 77054. NDC 15082-210-70