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
D-0858-2016
Product summary
- Firm
- Lymol Medical
- Event
- Event 73896
- Status
- Terminated
- Classification
- Class II
- Quantity
- 25,007 canisters
- Official record key
drug-enforcement:D-0858-2016
Official wording
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.
Code information: Lot #: 4L034, Exp. MAY 2017
Distribution pattern: Nationwide
Derived failure modes
-
Unknown
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.