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Food & drug recall · FDAJanuary 15, 2019Serious

Tris Pharma Inc. — infants* IBUPROFEN, Concentrated Ibuprofen Oral Suspension, USP (NSAID), 50 mg per 1.25 mL, Dye-Free Berry Flavor, 1 FL OZ (30 mL) bottle

Check whether yours is affected, then follow the instructions below.

What’s wrong

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

The Recall Registry rates this serious — FDA Class II: temporary or medically reversible health harm.

What to do

Check the lot numbers below against what you have, and follow the FDA recall notice for what to do with the affected product. If you use it daily, or it is for a child, your pharmacist can tell you whether it matters and what to use instead.

Who to contact: Recalling firm: Tris Pharma Inc.

The product

infants* IBUPROFEN, Concentrated Ibuprofen Oral Suspension, USP (NSAID), 50 mg per 1.25 mL, Dye-Free Berry Flavor, 1 FL OZ (30 mL) bottle, Distributed by Wal-Mart Stores, Inc., Bentonville, AR 72716, NDC 49035-125-24.

Details

Units affected
35,328 bottles
Recall date
January 15, 2019
Brand
Tris Pharma Inc.
Model, lot or SKU numbers
Lot#: 00717005A, Exp 02/19
Where it was distributed

One distributor who further distributed Nationwide in the USA

The official notice

This recall was issued by the U.S. Food and Drug Administration. The Recall Registry summarises it — always confirm the details at the source.

Their exact wording: “Tris Pharma Inc. — infants* IBUPROFEN, Concentrated Ibuprofen Oral Suspension, USP (NSAID), 50 mg per 1.25 mL, Dye-Free Berry Flavor, 1 FL OZ (30 mL) bottle, Distributed by Wal-Mart Stores, Inc., Bentonville, AR 72716, NDC 49035-125-24.”

Read it on FDA →

Worried about the other things in your house? You can write down what you have and be told if one is recalled — or, if you sell second-hand, check your whole stock at once.

Filed under: Children's medicine

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