Reported Feb 20, 2019 · Terminated
infants* IBUPROFEN, Concentrated Ibuprofen Oral Suspension, USP (NSAID), 50 mg per 1.25 mL, Dye-Free Berry Flavor, 1 FL…
Tris Pharma Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Tris Pharma Inc. · 2033 US Highway 130 · Monmouth Junction, NJ · 08852-3003
Is this the product you have?
- 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.
- Lot codes and dates
Lot#: 00717005AExp 02/19
- Amount recalled
- 35,328 bottles
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
- Nationwide
Why it was recalled
Superpotent Drug: recalled lots may have higher concentration of ibuprofen than amount labeled.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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