FentaNYL Citrate PF 200 mcg/ /0 recalled over sterility concerns

Recall date

March 6, 2025

Source

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

Official notice title

QuVa Pharma, Inc. recalls fentaNYL Citrate PF 200 mcg/100 mL (2 mcg/ml) /0.125% Bupivacaine HCl 125 mg/100 mL (1.25 mg/mL), 100 ml in NS Yellow C…

Recall number

D-0296-2025

FDA classification

Class II

Brand / firm

QuVa Pharma, Inc.

Sold / distributed

U.S. Nationwide

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 Citrate PF 200 mcg/100 mL (2 mcg/ml) /0.125% Bupivacaine HCl 125 mg/100 mL (1.25 mg/mL), 100 ml in NS Yellow CADD FSFF, Injection for Epidural Use (Not intended For IV Use), Compounded, For Institutional or Office Use Only, QuVa Pharma, 1075 West Park One Drive, Suite 100, Sugar Land, Tx 77478. NDC: 70092-1255-75