GlaxoSmithKline Recalls Ventolin HFA Inhalers Due to Defective Delivery System
GlaxoSmithKline is recalling specific lots of Ventolin HFA inhalers because some units have out-of-specification leak rates.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, and the defect involves a risk-of-harm product (respiratory medication) where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
GlaxoSmithKline, LLC is recalling 562,883 units of Ventolin HFA (albuterol sulfate) inhalers. The affected products are 90 mcg per actuation inhalers with 200 metered inhalations, NDC 0173-0682-20. The specific lots involved are 7ZP0634, 7ZP0810, and 7ZP0990, all with an expiration date of 5/18.
The recall was initiated due to a defective delivery system. Specifically, an elevated number of units tested out of specification for leak rate. This defect may affect the performance of the inhaler.
The affected products were distributed nationwide in the US and Puerto Rico. Consumers should stop using the affected inhalers and contact their healthcare provider or pharmacist for a replacement.
The recalled product
- Product
- VENTOLIN (ALBUTEROL SULFATE)
- Brand
- VENTOLIN
- Manufacturer
- GlaxoSmithKline, LLC
- Category
- Drug — Inhalation
- Affected units
- 562,883
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 (4)
- Lot#: 7ZP0634
- 7ZP0810
- 7ZP0990
- Exp. 5/18
Distribution
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