Lymol Medical recalls Sclerosol Intrapleural Aerosol (sterile talc powder), Intrapleural administration, 4 g Canister, Rx Only, Distributed b…

Recall date

April 28, 2016

Source

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

Recall number

D-0858-2016

FDA classification

Class II

Brand / firm

Lymol Medical

Sold / distributed

Nationwide

Why it was recalled

Defective Delivery System: Defective stem valve causes leakage of the propellant in the spray canister delivering no drug or an inadequate amount of the drug to be delivered.

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

What was recalled

Sclerosol Intrapleural Aerosol (sterile talc powder), Intrapleural administration, 4 g Canister, Rx Only, Distributed by: Bryan Corporation, Woburn, MA 01801, USA, NDC 63256-100-30