FDA Drug recall D-0858-2016
Sclerosol Intrapleural Aerosol (sterile talc powder), Intrapleural administration, 4 g Canister, Rx Only, Distributed by: Bryan Corporation…
- FDA Drug
- Class II
- terminated
- Published 2016-06-01
On 2016-06-01 the FDA classified a Class II recall of Sclerosol Intrapleural Aerosol (sterile talc powder), Intrapleural administration, 4 g Canister, Rx Only, Distributed by: Bryan Corporation… by Lymol Medical, citing 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.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0858-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-04-28 |
| Published | 2016-06-01 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Lymol Medical |
| Distribution | US |
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
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.
Identifiers
| code_info | Lot #: 4L034, Exp. MAY 2017 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0858-2016%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.