FENTANYL 2MCG/ML BUPIVACAINE 0 recalled over sterility concerns

Recall date

June 19, 2019

Source

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

Official notice title

RXQ Compounding LLC recalls FENTANYL 2MCG/ML BUPIVACAINE 0.125% IN NACL 0.9% SRY C-II, 50ML per syringe (C-II) RXQ Compounding, 340 West State Stre…

Recall number

D-1659-2019

FDA classification

Class II

Brand / firm

RXQ Compounding LLC

Sold / distributed

Nationwide USA

Why it was recalled

Lack of Assurance of Sterility

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 2MCG/ML BUPIVACAINE 0.125% IN NACL 0.9% SRY C-II, 50ML per syringe (C-II) RXQ Compounding, 340 West State Street, Unit 9, Athens, OH 45701. NDC: 70731-0207-89