Reported Jun 1, 2016 · Terminated

Sclerosol Intrapleural Aerosol (sterile talc powder), Intrapleural administration, 4 g Canister, Rx Only, Distributed…

Lymol Medical

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Lymol Medical · 4 Plympton St · Woburn, MA · 01801-2917

Is this the product you have?

  • Sclerosol Intrapleural Aerosol (sterile talc powder), Intrapleural administration, 4 g Canister, Rx Only
  • Distributed byBryan Corporation, Woburn, MA 01801, USA, NDC 63256-100-30
Lot codes and dates
    • Lot #: 4L034
    • Exp. MAY 2017
Amount recalled
25,007 canisters

Where it was sold

  • Nationwide

Why it was 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.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA drug enforcement) notice

Notice updated Mar 9, 2021 · Data as of Sep 19, 6:23 PM UTC

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