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Class II · ModerateActive recall

Ventolin

Could cause temporary or reversible harm; serious harm is unlikely.

Does this affect you?
Check your lot numberLot #: 6ZP9848, Exp 03/18; 6ZP0003, 6ZP9944, Exp 04/18.
Where it was soldNationwide in the USA and Puerto Rico
Find the lot number printed on your box or bottle. If it matches — and you take this medicine — call your pharmacist. Don't stop a prescribed medicine on your own.

What happened

Defective Delivery System: Elevated number of units with out of specification results for leak rate.

What to do

  1. Check the lot number and expiry on your medicine against the recall above.
  2. Talk to your pharmacist or doctor before changing anything — don't stop on your own.
  3. Report any problems to FDA MedWatch (1-800-FDA-1088 or fda.gov/medwatch).

Who makes it

Made byGlaxoSmithKline LLC
Brand nameVENTOLIN
Generic nameALBUTEROL SULFATE
Active ingredient(s)ALBUTEROL SULFATE
Distributed by / forGlaxoSmithKline, LLC
NDC0173-0682-20
Show the full FDA record
Full product labelVentolin HFA (albuterol sulfate) Inhalation Aerosol, 90 mcg per actuation, 200 Metered Inhalations, Net Wt. 18 g inhalers, Rx only, GlaxoSmithKline, Research Triangle Park, NC 22709, NDC 0173-0682-20.
Recalling firmGlaxoSmithKline, LLC
DistributionNationwide in the USA and Puerto Rico
Quantity593,088 inhalers
Recall initiated2017-03-22
Report date2017-04-12
Recall completed
Recall numberD-0626-2017
ClassificationClass II
FDA statusOngoing
Origin on fileZebulon NC United States

Related

Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗

This is public FDA recall information, not medical advice. A recall does not always mean your specific bottle is affected. Never stop a prescribed medicine without asking your pharmacist or doctor.