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.
Reported: February 20, 2019 Initiated: January 15, 2019 #D-0494-2019
Product Description
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.
Reason for Recall
Superpotent Drug: recalled lots may have higher concentration of ibuprofen than amount labeled.
Details
- Recalling Firm
- Tris Pharma Inc.
- Units Affected
- 35,328 bottles
- Distribution
- One distributor 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, 1 FL OZ (30 mL) bottle, Distributed by Wal-Mart Stores, Inc., Bentonville, AR 72716, NDC 49035-125-24.. Recalled by Tris Pharma Inc.. Units affected: 35,328 bottles.
Why was this product recalled? ▼
Superpotent Drug: recalled lots may have higher concentration of ibuprofen than amount labeled.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on February 20, 2019. Severity: Moderate. Recall number: D-0494-2019.
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