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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 numberMcKesson Medical-Surgical (MMS) is not able to identify the particular lot number received by a particular consignee for the recalled prescription products. Each letter includes the date it was distributed to customers and the dates that impacted product may have been shipped to the customer.
Where it was soldUSA nationwide.
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

cGMP deviations: Temperature abuse

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 bySandoz Inc
Brand nameALBUTEROL SULFATE
Generic nameALBUTEROL SULFATE
Active ingredient(s)ALBUTEROL SULFATE
Distributed by / forSandoz Inc
NDC0781-7296-85
Show the full FDA record
Full product labelAlbuterol Sulfate Inhalation Aerosol HFA 90 mcg, with Dose Indicator, 200 metered inhalations, Rx only, Distributed by: Sandoz Inc., NDC 0781-7296-85
Recalling firmMckesson Medical-Surgical Inc. Corporate Office
DistributionUSA nationwide.
Quantity1 aerosol
Recall initiated2022-04-13
Report date2022-06-15
Recall completed2023-11-30
Recall numberD-1024-2022
ClassificationClass II
FDA statusTerminated
Origin on fileRichmond VA 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.