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Class II · ModerateRecall completed

Valumeds Ibuprofen

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

Does this affect you?
Check your lot numberLot#: HJ6138
Where it was soldNY
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: Ibuprofen is being recalled in response to previous recall

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 bySPIRIT PHARMACEUTICALS LLC
Brand nameVALUMEDS IBUPROFEN
Generic nameIBUPROFEN
Active ingredient(s)IBUPROFEN
Distributed by / forSpirit Pharmaceuticals, LLC Ronkonkoma, NY 11779
NDC68210-0800-1
Show the full FDA record
Full product labelIbuprofen Tablets USP, 200 mg, 100-count bottles, OTC, Distributed By: Spirit Pharmaceuticals, LLC Ronkonkoma, NY 11779, NDC 68210-0800-1
Recalling firmSpirit Pharmaceuticals, LLC
DistributionNY
Quantity144 bottles
Recall initiated2018-01-10
Report date2018-03-14
Recall completed2021-01-20
Recall numberD-0583-2018
ClassificationClass II
FDA statusTerminated
Origin on fileRonkonkoma NY United States

Related

Ibuprofen 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.