infants* IBUPROFEN, Concentrated Ibuprofen Oral Suspension, USP (NSAID), 50 mg per 1.25 mL, Dye-Free Berry Flavor, 0.5 FL OZ (15 mL) bottle, Distributed by Wal-Mart Stores, Inc., Bentonville, AR 72716, NDC 49035-125-23, UPC 0 78742 02016 7.
Reported: December 26, 2018 Initiated: November 26, 2018 #D-0335-2019
Product Description
infants* IBUPROFEN, Concentrated Ibuprofen Oral Suspension, USP (NSAID), 50 mg per 1.25 mL, Dye-Free Berry Flavor, 0.5 FL OZ (15 mL) bottle, Distributed by Wal-Mart Stores, Inc., Bentonville, AR 72716, NDC 49035-125-23, UPC 0 78742 02016 7.
Reason for Recall
Superpotent Drug: recalled lots may have higher concentration of ibuprofen.
Details
- Recalling Firm
- Tris Pharma Inc.
- Units Affected
- 164,304 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 Berry Flavor, 0.5 FL OZ (15 mL) bottle, Distributed by Wal-Mart Stores, Inc., Bentonville, AR 72716, NDC 49035-125-23, UPC 0 78742 02016 7.. Recalled by Tris Pharma Inc.. Units affected: 164,304 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-0335-2019.
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