Drug product
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.
D-0494-2019
Product summary
- Firm
- Tris Pharma Inc.
- Event
- Event 81960
- Status
- Terminated
- Classification
- Class II
- Quantity
- 35,328 bottles
- Official record key
drug-enforcement:D-0494-2019
Official wording
Reason: Superpotent Drug: recalled lots may have higher concentration of ibuprofen than amount labeled.
Code information: Lot#: 00717005A, Exp 02/19
Distribution pattern: One distributor who further distributed Nationwide in the USA.
Derived failure modes
-
Potency or specification failure
Superpotent