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Class II · ModerateRecall completed

Albuterol Sulfate Syrup

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

Does this affect you?
Check your lot numberLot # 95113, exp 01/2017
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

Presence of Foreign Substance; presence of black particles describes generically as cellulose-based bundles of brown fibrous material.

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

Distributed by / forTeva Pharmaceuticals USA, Sellersville, PA ---
NDC0093-0661-16
Show the full FDA record
Full product labelAlbuterol Sulfate Syrup, 2 mg/ 5 mL, 473 mL bottle, Rx only, Manufactured in Canada by Contract Pharmaceuticals Limited, Canada, Manufactured For: Teva Pharmaceuticals USA, Sellersville, PA --- NDC 0093-0661-16
Recalling firmTeva North America
DistributionNationwide
Quantity8,052 bottles
Recall initiated2016-06-22
Report date2016-08-17
Recall completed2017-01-26
Recall numberD-1455-2016
ClassificationClass II
FDA statusTerminated
Origin on fileHorsham PA 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.