D-0858-2016 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- June 1, 2016
- Initiation Date
- April 28, 2016
- Termination Date
- March 9, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 25,007 canisters
Product Description
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 Pattern
Nationwide
Code Information
Lot #: 4L034, Exp. MAY 2017