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Class II: temporary or reversible health riskTerminated

Lymol Medical Sclerosol Intrapleural Aerosol Recall

Sclerosol Intrapleural Aerosol (sterile talc powder), Intrapleural administration, 4 g…

Lymol Medical · Woburn, MA

Risk level
Class II
Reported by FDA
Jun 1, 2016
Recall ID
D-0858-2016
Check your lot numberHow we source this data

Summary

Lymol Medical recalled Sclerosol Intrapleural Aerosol starting Apr 28, 2016. The FDA classified it as Class II (temporary or reversible health risk) and published enforcement report D-0858-2016 on Jun 1, 2016. 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. Status: Terminated.

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.

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

Lot numbers, UPCs & expiration codes

Lot #: 4L034, Exp. MAY 2017

Where it was sold

Nationwide

What to do if you have this product

  • Compare the lot number and expiration date on your package with the codes above.
  • Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
  • If you have symptoms you think are related, contact your doctor. In an emergency call 911.
  • Report side effects to FDA MedWatch at 1-800-FDA-1088.

Recall details

Recall number
D-0858-2016
Classification
Class II
Status
Terminated
Recall initiated
Apr 28, 2016
FDA report date
Jun 1, 2016
Quantity
25,007 canisters
Recall type
Voluntary: Firm initiated
Recalling firm
Lymol Medical

Original FDA data

Every field from FDA enforcement report D-0858-2016, exactly as published.

Show all FDA fields
City
Woburn
State
MA
Status
Terminated
Country
United States
Event ID
73896
Address
4 Plympton St
Code information
Lot #: 4L034, Exp. MAY 2017
Postal code
01801-2917
Report date
Jun 1, 2016
Product type
Drugs
Recall number
D-0858-2016
Classification
Class II
Recalling firm
Lymol Medical
Product quantity
25,007 canisters
Termination date
Mar 9, 2021
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.
Voluntary / mandated
Voluntary: Firm initiated
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
Distribution pattern
Nationwide
Recall initiation date
Apr 28, 2016
Initial firm notification
E-Mail
Center classification date
May 20, 2016

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0858-2016, published Jun 1, 2016. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: . Content last changed: .

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