Sclerosol Intrapleural Aerosol — Class II drug recall D-0858-2016
Terminated recall by Lymol Medical, reported 2016-06-01, distributed nationwide. Defective Delivery System: Defective stem valve causes leakage of the propellant in the spray canister deliver
| Recall number | D-0858-2016 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Lymol Medical, Woburn, MA, United States |
| Recall initiated | 2016-04-28 |
| Classified | 2016-05-20 |
| Reported by FDA | 2016-06-01 |
| Terminated | 2021-03-09 |
| Distributed | Nationwide (US) |
| Quantity | 25,007 canisters |
| Reason classes | packaging |
| NDC | 63256-0100-30 |
| Lot numbers | 4L034 |
| Expiration dates | 2017-05-20 |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0858-2016. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.