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Class II · ModerateRecall completed

Infants' Ibuprofen

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

Does this affect you?
Check your lot numberLot#: 4718, Exp 12/19
Where it was soldOne distributor who further distributed Nationwide in the USA.
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

Superpotent Drug: recalled lots may have higher concentration of ibuprofen than amount labeled.

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 / forCVS Pharmacy, Inc., One CVS Drive, Woonsocket, RI 02895, UPC 0 50428 39338 3
NDC59779-925-23
Show the full FDA record
Full product labelInfants' Ibuprofen, Concentrated Ibuprofen Oral Suspension, USP, (NSAID), 50 mg per 1.25 mL, Dye Free, Non-staining Berry Flavor, 0.5 FL OZ (15 mL) bottle, Distributed by: CVS Pharmacy, Inc., One CVS Drive, Woonsocket, RI 02895, UPC 0 50428 39338 3, NDC 59779-925-23.
Recalling firmTris Pharma Inc.
DistributionOne distributor who further distributed Nationwide in the USA.
Quantity46,080 bottles
Recall initiated2019-01-15
Report date2019-02-20
Recall completed2023-03-29
Recall numberD-0493-2019
ClassificationClass II
FDA statusTerminated
Origin on fileMonmouth Junction NJ United States

Related

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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.