The Recall Desk
HighFDA (Drugs)·D-1666-2012·Announced 2012-09-05

GlaxoSmithKline Recalls Ventolin Inhalers Due to Low Albuterol Content

GlaxoSmithKline is recalling 1.4 million Ventolin inhalers because the albuterol content may be below specification, potentially failing to deliver the proper metered dose.

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 hazard involves a risk of harm (under-dosing of a respiratory medication) where injury has not yet been reported, fitting the 'High' severity criteria for risk-of-harm products.

Plain-English summary

GlaxoSmithKline Inc is recalling 1,412,566 units of Ventolin (albuterol sulfate) Inhalation Aerosol, 90 mcg per actuation, 200 metered inhalations. The recall affects specific lots with expiration dates of January 2013, March 2013, and April 2013. The product is distributed nationwide.

The recall was initiated because the inhalers may not deliver the proper metered dose. The potential content of albuterol per dose is below specification, which could result in patients receiving less medication than intended.

Consumers with affected products should stop using them and contact their healthcare provider or pharmacist for a replacement. The affected lots are identified by specific lot numbers and expiration dates listed in the recall notice.

The recalled product

Product
VENTOLIN (ALBUTEROL SULFATE)
Brand
VENTOLIN
Manufacturer
GlaxoSmithKline Inc
Category
Drug — Inhalation Aerosol
Hazard
Affected units
1,412,566

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 (12)

  • Lot 1ZP7355 Exp. 01/13
  • 1ZP7749 Exp. 01/13
  • 1ZP8141 Exp. 01/13
  • 1ZP8147 Exp. 01/13
  • 1ZP7729 Exp. 01/13
  • 1ZP0414 Exp. 03/13
  • 1ZP0464 Exp. 03/13
  • 1ZP0570 Exp. 03/13
  • 1ZP0576 Exp. 03/13
  • 1ZP0919 Exp. 03/13
  • 2ZP4959 Exp. 04/13
  • 2ZP4966 Exp. 04/13

Distribution

Distributed nationwide across the United States.

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