Solu-Cortef 1MG in NS recalled over sterility concerns

Recall date

September 18, 2015

Source

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

Official notice title

Sentara Enterprises recalls Solu-Cortef (hydrocortisone) 1MG in NS, Packaged in 0.1ML Syringe, Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Indepen…

Recall number

D-0640-2016

FDA classification

Class II

Brand / firm

Sentara Enterprises

Sold / distributed

U.S. Including: VA, NC

Why it was recalled

Lack of Assurance of Sterility: Product sterility cannot be guaranteed.

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

What was recalled

Solu-Cortef (hydrocortisone) 1MG in NS, Packaged in 0.1ML Syringe, Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Independence Pkwy ste.300, Chesapeake, VA 23320-5176.