FDA recall D-0858-2016

Lymol Medical · Class II · drug

Product

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

Reason for recall

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.

Distribution

Nationwide

Key facts

Status: Terminated
Initiation date: 2016-04-28
Report date: 2016-06-01
Termination date: 2021-03-09
Voluntary/Mandated: Voluntary: Firm initiated
Location: Woburn, MA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0858-2016