FDAFDA · Food and drugs·Recall number D-0494-2019
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.
Published February 20, 2019 · Recall initiated: January 15, 2019
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Superpotent Drug: recalled lots may have higher concentration of ibuprofen than amount labeled.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Tris Pharma Inc.
- Distributor
- One distributor who further distributed Nationwide in the USA.
- Lot
- Lot#: 00717005A, Exp 02/19
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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