GlaxoSmithKline Recalls Ventolin Inhalers Due to Defective Delivery System
GlaxoSmithKline is recalling 593,088 Ventolin inhalers because some units have out-of-specification leak rates, potentially affecting drug delivery.
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 defect is a quality issue (leak rate) without reported injuries or illnesses, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
GlaxoSmithKline, LLC is recalling 593,088 units of Ventolin (albuterol sulfate) Inhalation Aerosol, 90 mcg per actuation, 200 metered inhalations. The recall involves specific lots: 6ZP9848 (Exp 03/18), 6ZP0003, and 6ZP9944 (Exp 04/18). The product was distributed nationwide in the USA and Puerto Rico.
The recall was initiated due to a defective delivery system, specifically an elevated number of units with out-of-specification results for leak rate. This defect may affect the performance of the inhaler.
Consumers with these specific lot numbers should stop using the product and contact their healthcare provider or pharmacist for guidance on replacement or alternative treatment options.
The recalled product
- Product
- VENTOLIN (ALBUTEROL SULFATE)
- Brand
- VENTOLIN
- Manufacturer
- GlaxoSmithKline, LLC
- Category
- Drug — Inhalation Aerosol
- Affected units
- 593,088
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 (5)
- Lot #: 6ZP9848
- Exp 03/18
- 6ZP0003
- 6ZP9944
- Exp 04/18.
Distribution
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