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
Reported: June 1, 2016 Initiated: April 28, 2016 #D-0858-2016
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.
Details
- Recalling Firm
- Lymol Medical
- Units Affected
- 25,007 canisters
- Distribution
- Nationwide
- Location
- Woburn, MA
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Lymol Medical. Units affected: 25,007 canisters.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on June 1, 2016. Severity: Moderate. Recall number: D-0858-2016.
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