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Class II · ModerateRecall completed

Combivent Respimat

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

Does this affect you?
Check your lot numberLot #: 408267, Exp 11/17
Where it was soldNationwide 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: Inhalers do not spray properly, emitting either no spray or a short transient spray.

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 byMade in Germany foreign manufacturer
Brand nameCOMBIVENT RESPIMAT
Generic nameIPRATROPIUM BROMIDE AND ALBUTEROL
Active ingredient(s)ALBUTEROL SULFATE, IPRATROPIUM BROMIDE
Distributed by / forBoehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, CT 06877 USA
NDC0597-0024-02
Show the full FDA record
Full product labelCOMBIVENT RESPIMAT (ipratropium bromide and albuterol) Inhalation Spray, 20 mcg/100 mcg per actuation*, 4 Grams, 120 Metered Doses per inhaler, Rx only, Distributed by Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, CT 06877 USA, Made in Germany, NDC 0597-0024-02.
Recalling firmBoehringer Ingelheim Roxane Inc
DistributionNationwide and Puerto Rico
Quantity358,647 inhalers
Recall initiated2015-07-24
Report date2015-08-05
Recall completed2017-02-01
Recall numberD-1279-2015
ClassificationClass II
FDA statusTerminated
Origin on fileColumbus OH United States

Related

Recent drug recallsCheck another medication

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.