FlaggedRx← Medication recall checkHome
Class II · ModerateRecall completed

Ipratropium Bromide And Albuterol Sulfate

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

Does this affect you?
Check your lot numbera) Lot D4E20A, exp 3/2016 and b) Lot D4C21A, exp 3/2016
Where it was soldNationwide
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

Lack of Assurance of Sterility; potential exposure to non-sterile lubricant during the filling process

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 byNephron Pharmaceuticals Corporation
Brand nameIPRATROPIUM BROMIDE AND ALBUTEROL SULFATE
Generic nameIPRATROPIUM BROMIDE AND ALBUTEROL SULFATE
Active ingredient(s)ALBUTEROL SULFATE, IPRATROPIUM BROMIDE
Distributed by / forNephron Pharmaceuticals Corp.
NDC0487-0201-03
Show the full FDA record
Full product labelIpratropium Bromide 0.5 mg and Albuterol Sulfate 3 mg Inhalation Solution, packaged in 30x3 mL Sterile Unit-Dose Vials, a) 30 count (NDC 0487-0201-03) and b) 60 count (NDC 0487-0201-60) vials per carton, Rx only, Nephron Pharmaceutical Corporation, Orlando, FL
Recalling firmNephron Pharmaceuticals Corp.
DistributionNationwide
Quantitya) 85,248 cartons and b) 35,292 cartons
Recall initiated2015-08-21
Report date2015-10-21
Recall completed2017-02-10
Recall numberD-0010-2016
ClassificationClass II
FDA statusTerminated
Origin on fileOrlando FL United States

Related

Albuterol recallsRecent 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.