Drug product
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.
D-0335-2019
Product summary
- Firm
- Tris Pharma Inc.
- Event
- Event 81354
- Status
- Terminated
- Classification
- Class II
- Quantity
- 164,304 bottles
- Official record key
drug-enforcement:D-0335-2019
Official wording
Reason: Superpotent Drug: recalled lots may have higher concentration of ibuprofen.
Code information: Lot #: 00717009A, Exp 02/19; 00717015A, Exp 04/19; 00717024A, Exp 08/19
Distribution pattern: One distributor in PA who further distributed Nationwide in the USA.
Derived failure modes
-
Potency or specification failure
Superpotent