Lymol Medical Recalls Sclerosol Intrapleural Aerosol Due to Defective Valve
Lymol Medical is recalling Sclerosol Intrapleural Aerosol because a defective stem valve may cause the canister to leak propellant, resulting in no drug or an inadequate dose being delivered.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a delivery system defect leading to inadequate dosing rather than a direct physical injury or contamination, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Lymol Medical is voluntarily recalling 25,007 canisters of Sclerosol Intrapleural Aerosol (sterile talc powder), 4 g Canister, NDC 63256-100-30. The product is distributed by Bryan Corporation and was available nationwide. The specific lot affected is 4L034, with an expiration date of May 2017.
The recall is due to a defective stem valve in the delivery system. This defect causes the propellant in the spray canister to leak, which may result in the delivery of no drug or an inadequate amount of the drug to the patient.
Healthcare providers and patients who have this specific lot of Sclerosol Intrapleural Aerosol should stop using it and contact Lymol Medical or their supplier for further instructions.
The recalled product
- 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
- Manufacturer
- Lymol Medical
- Category
- Drug — Inhalation / Aerosol
- Affected units
- 25,007
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot #: 4L034
- Exp. MAY 2017
Distribution
Distributed nationwide across the United States.
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