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.
Reported: December 26, 2018 Initiated: November 26, 2018 #D-0336-2019
Product Description
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.
Reason for Recall
Superpotent Drug: recalled lots may have higher concentration of ibuprofen.
Details
- Recalling Firm
- Tris Pharma Inc.
- Units Affected
- 19,488 bottles
- Distribution
- One distributor in PA who further distributed Nationwide in the USA.
- Location
- Monmouth Junction, NJ
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Tris Pharma Inc.. Units affected: 19,488 bottles.
Why was this product recalled? ▼
Superpotent Drug: recalled lots may have higher concentration of ibuprofen.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on December 26, 2018. Severity: Moderate. Recall number: D-0336-2019.
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