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Class II · ModerateRecall completed

Albuterol Sulfate

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

Does this affect you?
Check your lot numberLot #: A0654A, Exp 07/12; A0A62A, Exp 10/12
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

Lack of Assurance of Sterility

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, Orlando, FL 32811
Brand nameALBUTEROL SULFATE
Generic nameALBUTEROL SULFATE
Active ingredient(s)ALBUTEROL SULFATE
Distributed by / forNephron Pharmaceuticals Corp.
NDC0487-9501-60
Show the full FDA record
Full product labelAlbuterol Sulfate Inhalation Solution, 0.083%, 2.5 mg/3 mL Sterile Unit-Dose Vials, 60-count (60 x 3 mL Sterile Unit-Dose Vials) per carton, Rx only, Manufactured by: nephron pharmaceuticals corporation, Orlando, FL 32811, NDC 0487-9501-60.
Recalling firmNephron Pharmaceuticals Corp.
DistributionNationwide and Puerto Rico
Quantity56,028 cartons
Recall initiated2011-06-22
Report date2012-08-15
Recall completed2012-11-15
Recall numberD-1446-2012
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.