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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 #: 00717024A, Exp 08/19
Where it was soldOne distributor in PA 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.

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 / forFamily Dollar Services, Inc., 10301 Monroe Road, Matthews, NC 28105
NDC55319-250-23
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 Family Dollar Services, Inc., 10301 Monroe Road, Matthews, NC 28105, NDC 55319-250-23, UPC 0 32251 03374 2.
Recalling firmTris Pharma Inc.
DistributionOne distributor in PA who further distributed Nationwide in the USA.
Quantity19,488 bottles
Recall initiated2018-11-26
Report date2018-12-26
Recall completed2021-04-01
Recall numberD-0336-2019
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.