FDAFDA · Food and drugs·Recall number D-0336-2019
Infants' 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.
Published December 26, 2018 · Recall initiated: November 26, 2018
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Tris Pharma Inc.
- Distributor
- One distributor in PA who further distributed Nationwide in the USA.
- Lot
- Lot #: 00717024A, Exp 08/19
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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