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Recall Observatory FDA recall evidence

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

April 28, 2016

Class II

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

    reason.no_named_rule · v1.0.0

    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.